Browsing by Subject "MULTICENTER"

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  • Roininen, Saara; Laine, Outi; Kauppila, Marjut; Vesanen, Marko; Ramet, Maria; Sinisalo, Marjatta; Jantunen, Esa; Saily, Marjaana; Räty, Riikka; Elonen, Erkki; Wartiovaara-Kautto, Ulla (2017)
    Cerebral venous thrombosis (CVT) covers up to a third of all venous thromboses (VTs) detected in patients with acute lymphoblastic leukemia (ALL). It usually hampers patients' lives and may also endanger efficient leukemia treatment. Although many factors have been suggested to account for an elevated risk of VTs in patients with ALL, there still is a lack of studies focusing on CVTs and especially in the setting of adult ALL patients. We studied in our retrospective population-based cohort the occurrence, characteristics, as well as risk factors for VTs in 186 consecutively diagnosed Finnish adult ALL patients treated with a national pediatric-inspired treatment protocol ALL2000. In the risk factor analyses for VTs we found a distinction of the characteristics of the patients acquiring CVT from those with other kinds of VTs or without thrombosis. In contrast to previous studies we were also able to compare the effects of asparaginase in relation to CVT occurrence. Notably, more than half of the CVTs were diagnosed prior the administration of asparaginase which accentuates the role of other risk factors on the pathophysiology of CVT compared to truncal or central venous line (CVL) VTs in adult ALL patients.
  • Jääskeläinen, Iiro H.; Hagberg, Lars; Schyman, Tommy; Järvinen, Asko (2018)
    Background: Management practices of complicated skin and skin structure infections (cSSSI) were compared between two areas with similar healthcare structure and low prevalence of antimicrobial resistance.Methods: The high affinity to public health-care in the Nordic countries enabled population-based approach used in this retrospective study. The study population (n=460) consisted of all adult residents from Helsinki (Finland) and Gothenburg (Sweden) treated in hospital due to cSSSI during 2008-2011.Results: The majority of patients in Helsinki (57%) visited more than one ward during their hospital stay while in Gothenburg the majority of patients (85%) were treated in one ward only. Background and disease characteristics were largely similar in both cities but patients in Helsinki were younger [mean(SD) 59(18) versus 63(19) years, p=.0117], and greater proportions had diabetes (50% versus 32%, p
  • NORD STAR Study Grp; Hetland, Merete Lund; Haavardsholm, Espen A.; Rudin, Anna; Nordström, Dan; van Vollenhoven, Ronald (2020)
    OBJECTIVE To evaluate and compare benefits and harms of three biological treatments with different modes of action versus active conventional treatment in patients with early rheumatoid arthritis. DESIGN Investigator initiated, randomised, open label, blinded assessor, multiarm, phase IV study. SETTING Twenty nine rheumatology departments in Sweden, Denmark, Norway, Finland, the Netherlands, and Iceland between 2012 and 2018. PARTICIPANTS Patients aged 18 years and older with treatment naive rheumatoid arthritis, symptom duration less than 24 months, moderate to severe disease activity, and rheumatoid factor or anti-citrullinated protein antibody positivity, or increased C reactive protein. INTERVENTIONS Randomised 1:1:1:1, stratified by country, sex, and anti-citrullinated protein antibody status. All participants started methotrexate combined with (a) active conventional treatment (either prednisolone tapered to 5 mg/day, or sulfasalazine combined with hydroxychloroquine and intraarticular corticosteroids), (b) certolizumab pegol, (c) abatacept, or (d) tocilizumab. MAIN OUTCOME MEASURES The primary outcome was adjusted clinical disease activity index remission (CDAI RESULTS 812 patients underwent randomisation. The mean age was 54.3 years (standard deviation 14.7) and 68.8% were women. Baseline disease activity score of 28 joints was 5.0 (standard deviation 1.1). Adjusted 24 week CDAI remission rates were 42.7% (95% confidence interval 36.1% to 49.3%) for active conventional treatment, 46.5% (39.9% to 53.1%) for certolizumab pegol, 52.0% (45.5% to 58.6%) for abatacept, and 42.1% (35.3% to 48.8%) for tocilizumab. Corresponding absolute differences were 3.9% (95% confidence interval -5.5% to 13.2%) for certolizumab pegol, 9.4% (0.1% to 18.7%) for abatacept, and -0.6% (-10.1% to 8.9%) for tocilizumab. Key secondary outcomes showed no major differences among the four treatments. Differences in CDAI remission rates for active conventional treatment versus certolizumab pegol and tocilizumab, but not abatacept, remained within the prespecified non-inferiority margin of 15% (per protocol population). The total number of serious adverse events was 13 (percentage of patients who experienced at least one event 5.6%) for active conventional treatment, 20 (8.4%) for certolizumab pegol, 10 (4.9%) for abatacept, and 10 (4.9%) for tocilizumab. Eleven patients treated with abatacept stopped treatment early compared with 20-23 patients in the other arms. CONCLUSIONS All four treatments achieved high remission rates. Higher CDAI remission rate was observed for abatacept versus active conventional treatment, but not for certolizumab pegol or tocilizumab versus active conventional treatment. Other remission rates were similar across treatments. Non-inferiority analysis indicated that active conventional treatment was non-inferior to certolizumab pegol and tocilizumab, but not to abatacept. The results highlight the efficacy and safety of active conventional treatment based on methotrexate combined with corticosteroids, with nominally better results for abatacept, in treatment naive early rheumatoid arthritis.
  • Bonifazi, Francesca; Solano, Carlos; Wolschke, Christine; Sessa, Mariarosaria; Patriarca, Francesca; Zallio, Francesco; Nagler, Arnon; Selleri, Carmine; Risitano, Antonio Maria; Messina, Giuseppe; Bethge, Wolfgang; Herrera, Pilar; Sureda, Anna; Carella, Angelo Michele; Cimminiello, Michele; Guidi, Stefano; Finke, Juergen; Sorasio, Roberto; Ferra, Christelle; Sierra, Jorge; Russo, Domenico; Benedetti, Edoardo; Milone, Giuseppe; Benedetti, Fabio; Heinzelmann, Marion; Pastore, Domenico; Jurado, Manuel; Terruzzi, Elisabetta; Narni, Franco; Voelp, Andreas; Ayuk, Francis; Ruutu, Tapani; Kroeger, Nicolaus (2019)
    Background We previously showed that human anti-T-lymphocyte globulin (ATLG) plus ciclosporin and methotrexate given to patients with acute leukaemia in remission, having allogeneic haemopoietic stem-cell transplantation with peripheral blood stem cells from an HLA-identical sibling donor after myeloablative conditioning, significantly reduced 2-year chronic graft-versus-host disease (cGVHD) incidence and severity, without increasing disease relapse and infections, and improves cGVHD-free and relapse-free survival (cGRFS). The aim of an extended follow-up study was the assessment of long-term outcomes, which are, in this context, scarcely reported in the literature. We report unpublished data on quality of life (QoL) from the original study and the results of a follow-up extension. Methods In the original open-label study, patients with acute myeloid and lymphoblastic leukaemia in first or subsequent remission, having sibling HLA-identical allogeneic peripheral blood stem-cell transplantation, were randomly assigned (1:1) to receive ATLG plus standard GVHD prophylaxis with ciclosporin and short-term methotrexate (ATLG group) or standard GVHD prophylaxis without ATLG (non-ATLG group). Conditioning regimens were cyclophosphamide 120 mg/kg with either total body irradiation (12 Gy) or busulfan (12 . 8 mg/kg intravenously or 16 mg/kg orally), with or without etoposide (30-60 mg/kg). Randomisation was stratified according to centre and disease risk. The primary endpoint was cumulative incidence of cGVHD at 2 years. The primary and secondary endpoints, excluding QoL, have been published. QoL, assessed using European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-HDC29 questionnaires, was an unpublished secondary endpoint, which we now report here. A follow-up extension was then done, with the primary endpoint cumulative incidence of cGVHD. Enrolment has been completed for both studies. Findings In the original study, from Dec 14, 2006, to Feb 2, 2012, 161 patients were enrolled and 155 were randomly assigned to either the ATLG group (n=83) or to the non-ATLG group (n=72). In the follow-up study, which started on Feb 7, 2017, and was completed on June 30, 2017, 61 patients were included in the ATLG group and 53 were included in the non-ATLG group. Global health status showed a more favourable time course in the ATLG group compared with the non-ATLG group (p=0 . 02; treatment by visit interaction). ATLG was descriptively superior to non-ATLG at 24 months for physical function (points estimate -14.8 [95% CI -26.4 to-3.1]; p= 0.014) and social function (-19.1 [-38.0 to -0.2]; p=0.047), gastrointestinal side-effects (8 . 8 [2.5-15.1]; p=0 . 008) and effect on family (13.5 [1.2-25.8]; p=0.032). Extended follow-up (median 5 . 9 years [IQR 1.7-7.9]) confirmed a lower 5-year cGVHD incidence (30.0% [95% CI 21.4-41.9] vs 69.1% [59.1-80.1]; analysis for entire follow-up, p Interpretation The addition of ATLG to standard GVHD prophylaxis improves the probability of surviving without disease relapse and cGVHD after myeloablative peripheral blood stem-cell transplantation from an HLA-identical sibling donor for patients with acute leukaemia in remission. Further additional benefits are better QoL and shorter immunosuppressive treatment compared with standard GVHD prophylaxis without ATLG. Therefore, in this setting, ATLG plus standard GVHD prophylaxis should be preferred over the standard GVHD prophylaxis alone. Copyright (C) 2019 Elsevier Ltd. All rights reserved.
  • Kössi, Jyrki; Julkunen, Kristiina; Setälä, Marjaleena; Luostarinen, Markku (2016)
    Icodextrin (AdeptA (R)) has been shown to prevent postoperative adhesions in experimental and laparoscopic adhesiolysis surgery. However, the role of icodextrin in the prevention of adhesions in extensive gynecological surgery is unclear. The present study evaluated the effect of icodextrin on adhesion-related readmissions after extensive gynecological surgery. The hospital readmissions of 140 endometriosis patients operated on at Paijat-Hame Central Hospital in 2004-2008 with the use of icodextrin were retrospectively reviewed. The evaluation of readmissions focused on adhesion-related disorders and reoperations. If an abdominal or pelvic reoperation was performed, the extent of the adhesions was classified. The mean follow-up time was 6.53 years (range 0.21-9.83). After initial surgery, one patient (0.7 %) had adhesive small bowel obstruction. Another directly adhesion-related readmission occurred in two patients (1.4 %). The number of readmissions possibly related to adhesions was 3 (2.1 %). Abdominal or pelvic reoperation was performed on 54 patients (38.6 %): 4 in the open surgery group and 50 in the laparoscopic surgery group. The extent of the adhesions among the 54 reoperated patients was as follows: not mentioned in 16 patients, no adhesions in 14, mild in 18, moderate in 5, and severe in 1. There were two (3.7 %) bowel injuries (one enterotomy and one serosal lesion) in reoperations. The incidence of adhesion-related readmissions after the use of icodextrin is relatively low. This favorable result may be partly related to the laparoscopic technique. Despite the use of an anti-adhesion agent, in some patients, the extent of postoperative adhesions is severe.
  • Saraceni, Francesco; Labopin, Myriam; Forcade, Edouard; Kroeger, Nicolaus; Socie, Gerard; Niittyvuopio, Riitta; Cornelissen, Jan J.; Labussiere-Wallet, Helene; Blaise, Didier; Choi, Goda; Byrne, Jenny L.; Guillerm, Gaelle; Marchand, Tony; Esteve, Jordi; Bazarbachi, Ali; Savani, Bipin; Olivieri, Attilio; Nagler, Arnon; Mohty, Mohamad (2021)
    Limited data are currently available on the outcome of patients with acute myeloid leukemia (AML) undergoing allogeneic stem cell transplantation (allo-SCT) with a reduced performance status. We herein present the results of a registry study on 2,936 AML patients undergoing allo-SCT in first remission (CR1) with a Karnofsky Performance Status (KPS) score less than or equal to 80%. Two-year leukemia-free survival (LFS), overall survival (OS) and graft-versus-host disease (GVHD)-free, and relapse-free survival (GRFS) rates were 54%, 59%, and 41%, respectively. In multivariable analysis, patients with a KPS score = 80% had lower non-relapse mortality (NRM) and superior OS in comparison to patients with a KPS score
  • Öhman, Jonas; Harjola, Veli-Pekka; Karjalainen, Pasi; Lassus, Johan (2018)
    Background: It is unclear how to optimally monitor acute heart failure (AHF) patients. We evaluated the timely interplay of cardiac filling pressures, brain natriuretic peptides (BNPs), lung ultrasound (LUS) and symptoms during AHF treatment. Methods: We enrolled 60 patients who had been hospitalised for AHF. Patients were examined with a rapid cardiothoracic ultrasound (CaTUS) protocol, combining LUS and focused echocardiographic evaluation of cardiac filling pressures (i.e. medial E/e' and inferior vena cava index [IVCi]). CaTUS was done at 0, 12, 24 and 48 hours (3 hours) and on the day of discharge, alongside clinical evaluation and laboratory samples. Patients free of congestion (Blines or pleural fluid) on LUS at discharge were categorised as responders, whereas the rest were categorised as non-responders. Improvement in congestion parameters was evaluated separately in these groups. The effect of congestion parameters on prognosis was also analysed. Results: Responders experienced a significantly larger decline in E/e' (2.58 vs. 0.38, p=0.037) and dyspnoea visual analogue scale (1-10) score (7.68 vs. 3.57, p=0.007) during the first 12 hours of treatment, while IVCi and BNPs declined later without no such rapid initial decline. Among patients experiencing a >3 U decline in E/e' during the first 12 hours of treatment, 18/21 were to become responders (p Conclusion: E/e' seemed like the most useful congestion parameter for monitoring early treatment response, predicting prognostically beneficial resolution of pulmonary congestion.
  • van Gelder, Michel; Ziagkos, Dimitris; de Wreede, Liesbeth; van Biezen, Anja; Dreger, Peter; Gramatzki, Martin; Stelljes, Matthias; Andersen, Niels Smedegaard; Schaap, Nicolaas; Vitek, Antonin; Beelen, Dietrich; Lindstrom, Vesa; Finke, Juergen; Passweg, Jacob; Eder, Matthias; Machaczka, Maciej; Delgado, Julio; Krueger, William; Raida, Ludek; Socie, Gerard; Jindra, Pavel; Afanasyev, Boris; Wagner, Eva; Chalandon, Yves; Henseler, Anja; Schoenland, Stefan; Kroeger, Nicolaus; Schetelig, Johannes; CLL Subcomm Chronic Malignancies W; European Soc Blood Marrow Transpla (2017)
    Patients with chronic lymphocytic leukemia with del(17p) or del(11q) have poor long-term prognosis with targeted therapies. Conversely, this retrospective European Society for Blood and Marrow Transplantation registry study shows that young high cytogenetic risk responsive patients with human leukocyte antigen-matched donors have a high 8-year progression-free survival and low 2-year non-relapse mortality after allogeneic stem cell transplantation. This treatment then may compare favorably with targeted therapies for younger high cytogenetic risk patients. Background: Patients with genetically high-risk relapsed/refractory chronic lymphocytic leukemia have shorter median progression-free survival (PFS) with kinase-and BCL2-inhibitors (KI, BCL2i). Allogeneic hematopoietic stem cell transplantation (alloHCT) may result in sustained PFS, especially in younger patients because of its age-dependent non-relapse mortality (NRM) risk, but outcome data are lacking for this population. Patients and Methods: Risk factors for 2-year NRM and 8-year PFS were identified in patients <50 years in an updated European Society for Blood and Marrow Transplantation registry cohort (n = 197; median follow-up, 90.4 months) by Cox regression modeling, and predicted probabilities of NRM and PFS of 2 reference patients with favorable or unfavorable characteristics were plotted. Results: Predictors for poor 8-year PFS were no remission at the time of alloHCT (hazard ratio [HR], 1.7; 95% confidence interval [CI], 1.1-2.5) and partially human leukocyte antigen (HLA)-mismatched unrelated donor (HR, 2.8; 95% CI, 1.5-5.2). The latter variable also predicted a higher risk of 2-year NRM (HR, 4.0; 95% CI, 1.4-11.6) compared with HLA-matched sibling donors. Predicted 2-year NRM and 8-year PFS of a high cytogenetic risk (del(17p) and/or del(11q)) patient in remission with a matched related donor were 12% (95% CI, 3%-22%) and 54% (95% CI, 38%-69%), and for an unresponsive patient with a female partially HLA-matched unrelated donor 37% (95% CI, 12%-62%) and 38% (95% CI, 13%-63%). Conclusion: Low predicted NRM and high 8-year PFS in favorable transplant high cytogenetic risk patients compares favorably with outcomes with KI or BCL2i. Taking into account the amount of uncertainty for predicting survival after alloHCT and after sequential administration of KI and BCL2i, alloHCT remains a valid option for younger patients with high cytogenetic risk chronic lymphocytic leukemia with a well-HLA-matched donor. (C) 2017 Elsevier Inc. All rights reserved.
  • Cadilhac, Dominique A.; Dewey, Helen M.; Denisenko, Sonia; Bladin, Christopher F.; Meretoja, Atte (2019)
    BackgroundHospital costs for stroke are increasing and variability in care quality creates inefficiencies. In 2007, the Victorian Government (Australia) employed clinical facilitators for three years in eight public hospitals to improve stroke care. Literature on the cost implications of such roles is rare. We report changes in the costs of acute stroke care following implementation of this program.MethodsObservational controlled before-and-after cohort design. Standardised hospital costing data were compared pre-program (financial year 2006-07) and post-program (2010-11) for all admitted episodes of stroke or transient ischaemic attack (TIA) using ICD-10 discharge codes. Costs in Australian dollars (AUD) were adjusted to a common year 2010. Generalised linear regression models were used for adjusted comparisons.ResultsA 20% increase in stroke and TIA episodes was observed: 2624 pre-program (age>75years: 53%) and 3142 post-program (age>75years: 51%); largely explained by more TIA admissions (up from 785 to 1072). Average length of stay reduced by 22% (pre-program 7.3days to post-program 5.7days, p
  • Perner, Anders; Haase, Nicolai; Wetterslev, Jorn; Aneman, Anders; Tenhunen, Jyrki; Guttormsen, Anne Berit; Klemenzson, Gudmundur; Pott, Frank; Bodker, Karen Doris; Badstolokken, Per Martin; Bendtsen, Asger; Soe-Jensen, Peter; Tousi, Hamid; Bestle, Morten; Pawlowicz, Malgorzata; Winding, Robert; Bulow, Hans-Henrik; Kancir, Claude; Steensen, Morten; Nielsen, Jonas; Fogh, Bjarne; Madsen, Kristian R.; Larsen, Nils H.; Carlsson, Marcela; Wiis, Jorgen; Petersen, John Asger; Iversen, Susanne; Schoidt, Ole; Leivdal, Siv; Berezowicz, Pawel; Pettilä, Ville; Ruokonen, Esko; Klepstad, Pal; Karlsson, Sari; Kaukonen, Maija; Rutanen, Juha; Karason, Sigurbergur; Kjaelgaard, Anne Lene; Holst, Lars Brokso; Wernerman, Jan; Scandinavian Critical Care Trials (2011)
  • Pettilä, Ville; Hjortrup, Peter Buhl; Jakob, Stephan M.; Wilkman, Erika; Perner, Anders; Takala, Jukka (2016)
    The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. We searched for original articles presenting randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58 % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2-17) were reported. Only 2 (8 %) trials provided adequate data to confirm that their control group treatment represented usual care. Recent trials in septic shock provide inadequate data on the control group treatment and hemodynamic values. We propose a standardized trial dataset to be created and validated, comprising characteristics of patient population, interventions administered, hemodynamic values achieved, surrogate organ dysfunction, and mortality outcomes, to allow better analysis and interpretation of future trial results.
  • Cantu, Paolo; Tenca, Andrea; Parzanese, Ilaria; Penagini, Roberto (2016)
    There is growing interest in using covered self-expandable metal stents for the treatment of benign biliary conditions, and the presence of anastomotic biliary strictures and leaks after liver transplantation provide a valuable opportunity for testing them. The performance of the stents is encouraging, and the technical success rate is high. They provide larger diameter dilation and are easily removed, and can potentially limit costs by reducing the number of procedures needed to treat anastomotic biliary strictures. However, drawbacks such as sub-optimal tolerability and migration may affect both patient management and costs. New stent designs are currently being evaluated. Randomized controlled trials and cost-effectiveness analyses comparing covered metal stents with multiple plastic stent endotherapy are warranted in order to define the role of the former as first-line or rescue treatment. (C) 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
  • Rainio, Mia; Lindström, Outi; Udd, Marianne; Louhimo, Johanna; Kylänpää, Leena (2017)
    Background Nonsteroidal anti-inflammatory drugs have an inhibitory role in pathogenesis of pancreatitis. Guidelines from the European Society of Gastrointestinal Endoscopy recommend routine rectal administration of 100 mg of diclofenac or indomethacin immediately before or after ERCP for all patients without contraindications. Aims Our aim was to evaluate the effect of diclofenac in preventing post-ERCP pancreatitis (PEP) in a high-volume, low-PEP-risk ERCP unit. Methods The rate and severity of PEP were compared in groups of 1000 historical controls prior to the routine use of diclofenac and in 1000 patients receiving 100 mg diclofenac before ERCP. Results PEP occurred in 56 (2.8%) of the 2000 patients, and the rate of the pancreatitis was 2.8% in control group and 2.8% in diclofenac group (p = 1.000). The PEP rate among the native papilla patients was 3.9% in control group and 3.6% in diclofenac group (p = 0.803). In subgroup analysis of patients with a high risk of PEP, diclofenac neither prevented PEP nor made its course milder. Conclusions In an unselected patient population in a center with a low incidence of PEP, diclofenac seems to have no beneficial effect.
  • Joensuu, Heikki; Blay, Jean-Yves; Comandone, Alessandro; Martin-Broto, Javier; Fumagalli, Elena; Grignani, Giovanni; Del Muro, Xavier Garcia; Adenis, Antoine; Valverde, Claudia; Pousa, Antonio Lopez; Olivier, Bouche; Italiano, Antoine; Bauer, Sebastian; Barone, Carlo; Weiss, Claudia; Crippa, Stefania; Camozzi, Maura; Castellana, Ramon; Le Cesne, Axel (2017)
    Background: This multicentre phase II trial (DOVIGIST) evaluated the antitumour activity of dovitinib as second-line treatment of patients with gastrointestinal stromal tumour (GIST) refractory to imatinib or who do not tolerate imatinib. Methods: Patients received oral dovitinib 500 mg day(-1), 5 days on/2 days off, until GIST progression or unacceptable toxicity, with an objective to evaluate efficacy, assessed as the disease control rate (DCR) at 12 weeks. Tumour assessment and response to dovitinib therapy were evaluated by Response Evaluation Criteria In Solid Tumours (RECIST v1.1) and the Choi criteria. Secondary objectives included assessment of progression-free survival (PFS), safety and tolerability, and DCR at the end of treatment. Results: Thirty-eight of the 39 patients enrolled had histologically confirmed GIST. The DCR at 12 weeks was 52.6% (90% confidence interval (CI), 38.2-66.7%) meeting the preset efficacy criterion for the primary end point. The objective response rate (complete response+partial response) was 2.6% (1 of 38; 90% CI, 0.1-11.9%), and 5.3% (n = 2; 90% CI, 0.9-15.7%) at the end of the study. The median PFS was 4.6 months (90% CI, 2.8-7.4 months). Dose interruption was required in 26 patients (66.7%), of which 18 (69.2%) were due to adverse events. The most frequently observed grade 3 adverse events included hypertension (n = 7), fatigue (n = 5), vomiting (n = 4), hypertriglyceridaemia (n = 4), and gamma-glutamyltransferase increase (n = 4). Conclusions: Dovitinib is an active treatment for patients with GIST who are intolerant to imatinib or whose GIST progresses on imatinib.
  • Calabro, Lorenzo; Bougouin, Wulfran; Cariou, Alain; De Fazio, Chiara; Skrifvars, Markus; Soreide, Eldar; Creteur, Jacques; Kirkegaard, Hans; Legriel, Stephane; Lascarrou, Jean-Baptiste; Megarbane, Bruno; Deye, Nicolas; Taccone, Fabio Silvio (2019)
    Background Although targeted temperature management (TTM) is recommended in comatose survivors after cardiac arrest (CA), the optimal method to deliver TTM remains unknown. We performed a meta-analysis to evaluate the effects of different TTM methods on survival and neurological outcome after adult CA. Methods We searched on the MEDLINE/PubMed database until 22 February 2019 for comparative studies that evaluated at least two different TTM methods in CA patients. Data were extracted independently by two authors. We used the Newcastle-Ottawa Scale and a modified Cochrane ROB tools for assessing the risk of bias of each study. The primary outcome was the occurrence of unfavorable neurological outcome (UO); secondary outcomes included overall mortality. Results Our search identified 6886 studies; 22 studies (n = 8027 patients) were included in the final analysis. When compared to surface cooling, core methods showed a lower probability of UO (OR 0.85 [95% CIs 0.75-0.96]; p = 0.008) but not mortality (OR 0.88 [95% CIs 0.62-1.25]; p = 0.21). No significant heterogeneity was observed among studies. However, these effects were observed in the analyses of non-RCTs. A significant lower probability of both UO and mortality were observed when invasive TTM methods were compared to non-invasive TTM methods and when temperature feedback devices (TFD) were compared to non-TFD methods. These results were significant particularly in non-RCTs. Conclusions Although existing literature is mostly based on retrospective or prospective studies, specific TTM methods (i.e., core, invasive, and with TFD) were associated with a lower probability of poor neurological outcome when compared to other methods in adult CA survivors (CRD42019111021).
  • Kurppa, Kalle; Rasanen, Tiia; Collin, Pekka; Iltanen, Sari; Huhtala, Heini; Ashorn, Merja; Saavalainen, Paivi; Haimila, Katri; Partanen, Jukka; Maki, Markku; Kaukinen, Katri (2012)
  • Biancari, Fausto; Mariscalco, Giovanni; Mariani, Silvia; Saari, Petri; Satta, Jari; Juvonen, Tatu (2016)
    Purpose: To determine the efficacy of thoracic endovascular aortic repair (TEVAR) for degenerative aneurysm involving only the descending thoracic aorta (DTAA). Methods: An English-language literature review was performed through PubMed, Scopus, and Google Scholar to identify any study evaluating the outcomes of TEVAR for DTAA. The main endpoints of this analysis were all-cause 30-day and late postoperative mortality. Secondary outcome measures were procedure success, vascular access complications, paraplegia, stroke, early endoleaks during the index hospitalization, aneurysm-related death, reinterventions, and conversion to open repair. To control for the anticipated heterogeneity among small observational studies, absolute values and means were pooled using random effects models; the results are expressed as pooled proportions, means, or risk ratio (RR) with 95% confidence intervals (CIs). Results: Eleven studies reporting on 673 patients (mean age 72.6 years, mean aneurysm diameter 62.9 cm) with DTAA were selected for the analysis. Technical success was reported in 91.0% of patients, and vascular access complications requiring repair were encountered in 9.7% of cases. Pooled overall 30-day, 1-year, 2-year, and 3-year survival rates were 96.0%, 80.3%, 77.3%, and 74.0%, respectively. Five studies compared the results of TEVAR after elective (n=151) and urgent/emergent procedure (n=77); the latter was a predictor of 30-day mortality (17.1% vs 1.8%, RR 3.83, 95% CI 1.18 to 12.40, p=0.025). Paraplegia occurred in 3.2% of patients and was permanent in 1.4% of patients. The stroke rate was 2.7%. Early type I endoleak was observed in 7.3%, type II endoleak in 2.0%, and type III in 1.2% of patients. The mean follow-up of 9 studies was 22.3 months. At 3 years, freedom from reintervention was 90.3%. Death secondary to aneurysm rupture and/or fistula was reported in 3.2% of patients. Conclusion: Current results indicate that TEVAR for DTAA can be performed with rather high technical success, low postoperative morbidity, and good 3-year survival.
  • EXTEND Investigator; ECASS-4 Investigator; EPITHET Investigator; Campbell, Bruce C.; Ma, Henry; Curtze, Sami; Donnan, Geoffrey A.; Kaste, Markku (2019)
    Background Stroke thrombolysis with alteplase is currently recommended 0-4.5 h after stroke onset. We aimed to determine whether perfusion imaging can identify patients with salvageable brain tissue with symptoms 4.5 h or more from stroke onset or with symptoms on waking who might benefit from thrombolysis. Methods In this systematic review and meta-analysis of individual patient data, we searched PubMed for randomised trials published in English between Jan 1, 2006, and March 1, 2019. We also reviewed the reference list of a previous systematic review of thrombolysis and searched ClinicalTrials. gov for interventional studies of ischaemic stroke. Studies of alteplase versus placebo in patients (aged =18 years) with ischaemic stroke treated more than 4.5 h after onset, or with wake-up stroke, who were imaged with perfusion-diffusion MRI or CT perfusion were eligible for inclusion. The primary outcome was excellent functional outcome (modified Rankin Scale [mRS] score 0-1) at 3 months, adjusted for baseline age and clinical severity. Safety outcomes were death and symptomatic intracerebral haemorrhage. We calculated odds ratios, adjusted for baseline age and National Institutes of Health Stroke Scale score, using mixed-effects logistic regression models. This study is registered with PROSPERO, number CRD42019128036. Findings We identified three trials that met eligibility criteria: EXTEND, ECASS4-EXTEND, and EPITHET. Of the 414 patients included in the three trials, 213 (51%) were assigned to receive alteplase and 201 (49%) were assigned to receive placebo. Overall, 211 patients in the alteplase group and 199 patients in the placebo group had mRS assessment data at 3 months and thus were included in the analysis of the primary outcome. 76 (36%) of 211 patients in the alteplase group and 58 (29%) of 199 patients in the placebo group had achieved excellent functional outcome at 3 months (adjusted odds ratio [OR] 1.86, 95% CI 1.15-2.99, p=0.011). Symptomatic intracerebral haemorrhage was more common in the alteplase group than the placebo group (ten [5%] of 213 patients vs one [<1%] of 201 patients in the placebo group; adjusted OR 9.7, 95% CI 1.23-76.55, p=0.031). 29 (14%) of 213 patients in the alteplase group and 18 (9%) of 201 patients in the placebo group died (adjusted OR 1.55, 0.81-2.96, p=0.66). Interpretation Patients with ischaemic stroke 4.5-9 h from stroke onset or wake-up stroke with salvageable brain tissue who were treated with alteplase achieved better functional outcomes than did patients given placebo. The rate of symptomatic intracerebral haemorrhage was higher with alteplase, but this increase did not negate the overall net benefit of thrombolysis. Copyright (c) 2019 Elsevier Ltd. All rights reserved.
  • Skrifvars, Markus B.; Martin-Loeches, Ignacio (2016)
  • Kauppila, Joonas H.; Ohtonen, Pasi; Karttunen, Tuomo J.; Kokkola, Arto; Laine, Simo; Rantanen, Tuomo; Ristimäki, Ari; Räsänen, Jari V.; Saarnio, Juha; Sihvo, Eero; Toikkanen, Vesa; Tyrvänen, Tuula (2019)
    Introduction Surgery for oesophageal and gastric cancers is associated with high morbidity, mortality and poor quality of life postoperatively. The Finnish National Esophago-Gastric Cancer Cohort has been established with the aim of identifying factors that could contribute to improved outcomes in oesophago-gastric cancer. Methods and analysis All patients with oesophageal and gastric cancer diagnosed in Finland between 1987 and 2015 will be identified from the Finnish national registries. The Finnish Cancer Registry and Finnish Patient Registry will be used to identify patients that fulfil the inclusion criteria for the study: (1) diagnosis of oesophageal, gastro-oesophageal junction, or gastric cancer, (2) any surgical treatment for the diagnosed cancer and (3) age of 18 or over at the time of diagnosis. Clinical variables and complication information will be retrieved in extensive data collection from the medical records of the relevant Finnish hospitals and complete follow-up for vital status from Statistics Finland. Primary end point is overall all-cause mortality and secondary endpoints include complications, reoperations, medication use and sick leaves. Sub-studies will be implemented within the cohort to investigate specific populations undergoing oesophageal and gastric cancer surgery. The initial estimated sample size is 1800 patients with surgically treated oesophageal cancer and 7500 patients with surgically treated gastric cancer. Ethics and dissemination The study has been approved by the Ethical Committee in Northern Ostrobothnia, Finland and The National Institute for Health and Welfare, Finland. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journals.