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FIBrinogen REplenishment in Surgery (FIBRES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03037424
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : May 14, 2019
Information provided by (Responsible Party):
Jo Carroll, University Health Network, Toronto

Brief Summary:

This is a pragmatic, prospective, multi-center, randomized, active-control, single-blinded, non-inferiority phase 3 trial in adult cardiac surgical patients. Up to 12 Canadian hospitals will participate, and the trial will require up to 2 years for patient recruitment.

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.

Condition or disease Intervention/treatment Phase
Deficiency; Fibrinogen, Acquired Drug: Octafibrin Drug: Cryoprecipitate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 827 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Multi-center, Randomized, Active-control, Non-inferiority Study Comparing Fibrinogen Concentrate With Cryoprecipitate for the Treatment of Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arm Intervention/treatment
Active Comparator: Fibrinogen concentrate Octafibrin Drug: Octafibrin
Octafibrin will be administered when the blood bank receives an order for fibrinogen supplementation

Active Comparator: Cryoprecipitate Drug: Cryoprecipitate
Cryoprecipitate will be administered when the blood bank receives an order for fibrinogen supplementation

Primary Outcome Measures :
  1. The primary endpoint, which is of efficacy, is the comparison of the total number of units of ABPs (RBCs, pooled or apheresis platelets, and plasma) administered during the first 24 hours after termination of CPB. [ Time Frame: 24 hours ]
    The number of ABPs (red blood cells [RBCs], pooled or apheresis platelets, and plasma) administered during the first 24 hours after termination of CPB

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

1. Patients undergoing index cardiac surgery with CPB in whom fibrinogen supplementation is ordered in accordance with accepted clinical standards (significant hemorrhage and known or presumed hypofibrinogenemia).

Exclusion Criteria:

1. Receipt of fibrinogen rich products (fibrinogen concentrate or cryoprecipitate) within 24 hours before surgery 2. History of severe allergic reaction to cryoprecipitate or fibrinogen concentrate 3. Refusal of ABPs, fibrinogen concentrate or cryoprecipitate due to religious or other reasons 4. Fibrinogen level known to be >3.0 g/L within 30 minutes of IMP order (to eliminate the risk of raising patients' fibrinogen levels to >4.0 g/L with supplementation 5. Known pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03037424

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Canada, British Columbia
Fraser University Royal Columbia
Vancouver, British Columbia, Canada, V3L 3W7
Canada, Manitoba
University of Manitoba, St Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Hamilton Health Science Centre, McMaster University
Hamilton, Ontario, Canada, L8S 3Z5
Kingston General Hsopital
Kingston, Ontario, Canada, K7L 3N6
London Health Science Centre
London, Ontario, Canada, N6A 5A5
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Tornoto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal Heart Institute
Montréal, Quebec, Canada, H1T 1C8
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Keyvan Karkouti, MD University Health Network, Toronto
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jo Carroll, Manager Anesthesia Research, University Health Network, Toronto Identifier: NCT03037424    
Other Study ID Numbers: 16-5636-A
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jo Carroll, University Health Network, Toronto:
Cardiac Surgery