FIBrinogen REplenishment in Surgery (FIBRES)
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| ClinicalTrials.gov Identifier: NCT03037424 |
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Recruitment Status :
Completed
First Posted : January 31, 2017
Last Update Posted : May 14, 2019
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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 |
| 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 |
| 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 |
- 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
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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
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 ClinicalTrials.gov identifier (NCT number): NCT03037424
| 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 | |
| Canada | |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval | |
| Quebec, Canada, G1V 4G5 | |
| Principal Investigator: | Keyvan Karkouti, MD | University Health Network, Toronto |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jo Carroll, Manager Anesthesia Research, University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT03037424 History of Changes |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cyroprecipitate Fibrinogen Cardiac Surgery |