Deficiency; Fibrinogen, Acquired Clinical Trial
— FIBRESOfficial 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
| Verified date | May 2019 |
| Source | University Health Network, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 827 |
| Est. completion date | March 27, 2019 |
| Est. primary completion date | November 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hamilton Health Science Centre, McMaster University | Hamilton | Ontario |
| Canada | Kingston General Hsopital | Kingston | Ontario |
| Canada | London Health Science Centre | London | Ontario |
| Canada | Montreal Heart Institute | Montréal | Quebec |
| Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
| Canada | Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval | Quebec | |
| Canada | St Michael's Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Science Centre | Toronto | Ontario |
| Canada | Tornoto General Hospital, University Health Network | Toronto | Ontario |
| Canada | Fraser University Royal Columbia | Vancouver | British Columbia |
| Canada | University of Manitoba, St Boniface General Hospital | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| University Health Network, Toronto |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | The number of ABPs (red blood cells [RBCs], pooled or apheresis platelets, and plasma) administered during the first 24 hours after termination of CPB | 24 hours |