Study Results
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Basic Information
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COMPLETED
PHASE3
827 participants
INTERVENTIONAL
2017-02-22
2019-03-27
Brief Summary
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Twelve-hundred bleeding adult cardiac surgical patients who require fibrinogen supplementation due to acquired hypofibrinogenemia after CPB will be included. Patients will be randomized to receive equivalent doses of either fibrinogen concentrate (Octafibrin) or cryoprecipitate when the blood bank receives the first order for fibrinogen supplementation and deems it to be in accordance with accepted clinical standards. Thereafter, patients will be treated according to their assigned group each time fibrinogen supplementation is ordered during the treatment period (24 hours after termination of CPB). No other aspects of care will be modified.
The primary efficacy outcome will be the number of Allogeneic blood products (ABP) (red blood cells \[RBCs\], pooled or apheresis platelets, and plasma) administered during the first 24 hours after termination of CPB. Safety outcomes will be measured for the first 28 days after surgery, which is the duration of participation of each patient in the trial. Comparisons will be by intention-to-treat (ITT) (primary) and per-protocol (PP) analysis. One interim analysis will be conducted after 600 patients have been treated to determine whether the study should be terminated for safety reasons, demonstrated non-inferiority or futility reasons.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fibrinogen concentrate Octafibrin
Octafibrin
Octafibrin will be administered when the blood bank receives an order for fibrinogen supplementation
Cryoprecipitate
Cryoprecipitate
Cryoprecipitate will be administered when the blood bank receives an order for fibrinogen supplementation
Interventions
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Octafibrin
Octafibrin will be administered when the blood bank receives an order for fibrinogen supplementation
Cryoprecipitate
Cryoprecipitate will be administered when the blood bank receives an order for fibrinogen supplementation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Jo Carroll
Manager Anesthesia Research
Principal Investigators
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Keyvan Karkouti, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Fraser University Royal Columbia
Vancouver, British Columbia, Canada
University of Manitoba, St Boniface General Hospital
Winnipeg, Manitoba, Canada
Hamilton Health Science Centre, McMaster University
Hamilton, Ontario, Canada
Kingston General Hsopital
Kingston, Ontario, Canada
London Health Science Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Tornoto General Hospital, University Health Network
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval
Québec, , Canada
Countries
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References
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Devine C, Bartoszko J, Callum J, Karkouti K; FIBRES Study Investigators. Weight-adjusted dosing of fibrinogen concentrate and cryoprecipitate in the treatment of hypofibrinogenaemic bleeding adult cardiac surgical patients: a post hoc analysis of the Fibrinogen Replenishment in cardiac surgery randomised controlled trial. BJA Open. 2022 Jun 9;2:100016. doi: 10.1016/j.bjao.2022.100016. eCollection 2022 Jun.
Bartoszko J, Martinez-Perez S, Callum J, Karkouti K; FIBRES Study Investigators. Impact of cardiopulmonary bypass duration on efficacy of fibrinogen replacement with cryoprecipitate compared with fibrinogen concentrate: a post hoc analysis of the Fibrinogen Replenishment in Surgery (FIBRES) randomised controlled trial. Br J Anaesth. 2022 Sep;129(3):294-307. doi: 10.1016/j.bja.2022.05.012. Epub 2022 Jun 28.
Callum J, Farkouh ME, Scales DC, Heddle NM, Crowther M, Rao V, Hucke HP, Carroll J, Grewal D, Brar S, Bussieres J, Grocott H, Harle C, Pavenski K, Rochon A, Saha T, Shepherd L, Syed S, Tran D, Wong D, Zeller M, Karkouti K; FIBRES Research Group. Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial. JAMA. 2019 Nov 26;322(20):1966-1976. doi: 10.1001/jama.2019.17312.
Karkouti K, Callum J, Rao V, Heddle N, Farkouh ME, Crowther MA, Scales DC. Protocol for a phase III, non-inferiority, randomised comparison of a new fibrinogen concentrate versus cryoprecipitate for treating acquired hypofibrinogenaemia in bleeding cardiac surgical patients: the FIBRES trial. BMJ Open. 2018 Apr 20;8(4):e020741. doi: 10.1136/bmjopen-2017-020741.
Other Identifiers
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16-5636-A
Identifier Type: -
Identifier Source: org_study_id
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