Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery : post hoc analysis and interpretation of phase III results

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http://hdl.handle.net/10138/306882

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Rahe-Meyer , N , Levy , J H , Mazer , C D , Schramko , A , Klein , A A , Brat , R , Okita , Y , Ueda , Y , Schmidt , D S & Gill , R 2019 , ' Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery : post hoc analysis and interpretation of phase III results ' , Interactive cardiovascular and thoracic surgery. , vol. 28 , no. 4 , pp. 566-574 . https://doi.org/10.1093/icvts/ivy302

Title: Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery : post hoc analysis and interpretation of phase III results
Author: Rahe-Meyer, Niels; Levy, Jerrold H.; Mazer, C. David; Schramko, Alexey; Klein, Andrew A.; Brat, Radim; Okita, Yutaka; Ueda, Yuichi; Schmidt, Dirk Steffen; Gill, Ravi
Contributor: University of Helsinki, HUS Perioperative, Intensive Care and Pain Medicine
Date: 2019-04
Language: eng
Number of pages: 9
Belongs to series: Interactive cardiovascular and thoracic surgery.
ISSN: 1569-9293
URI: http://hdl.handle.net/10138/306882
Abstract: OBJECTIVES: In a multicentre, randomized-controlled, phase III trial in complex cardiovascular surgery (Randomized Evaluation of Fibrinogen vs Placebo in Complex Cardiovascular Surgery: REPLACE), single-dose human fibrinogen concentrate (FCH) was associated with the transfusion of increased allogeneic blood products (ABPs) versus placebo. Post hoc analyses were performed to identify possible reasons for this result. METHODS: We stratified REPLACE results by adherence to the transfusion algorithm, pretreatment fibrinogen level (2g/l) and whether patients were among the first 3 treated at their centre. RESULTS: Patients whose treatment was adherent with the transfusion algorithm [FCH, n=47 (60.3%); placebo, n=57 (77.0%); P=0.036] received smaller quantities of ABPs than those with non-adherent treatment (P2g/l and fewer patients undergoing thoracoabdominal aortic aneurysm repair. CONCLUSIONS: None of the patient stratifications provided a clear explanation for the lack of efficacy seen for FCH in the REPLACE trial versus the positive phase II outcomes. However, together, the 3 factors demonstrated trends favouring FCH. Less familiarity with the protocol and procedures and unavoidable differences in the study populations may explain the differences seen between the phase II study and REPLACE.
Subject: Blood coagulation
Cardiovascular surgical procedures
Fibrinogen
Haemorrhage
1ST-LINE THERAPY
CONCENTRATE
REPLACEMENT
MANAGEMENT
TRANSFUSION
EFFICACY
SAFETY
3126 Surgery, anesthesiology, intensive care, radiology
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