Status:
UNKNOWN
Factor Replacement in Surgery
Lead Sponsor:
University Health Network, Toronto
Conditions:
Bleeding in Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicentre, randomized, active-control, pragmatic, Phase 2 pilot study in adult cardiac surgery patients. Two Canadian hospitals will participate, and it is estimated that the study will ta...
Eligibility Criteria
Inclusion
- Patients undergoing any index cardiac surgery with or without CPB in whom coagulation factor replacement with PCC or FP is ordered in the operating room for:
- Management of bleeding, or
- Anticipated bleeding in a patient who has
- been on-pump for \>2 hours, or
- undergone a complex procedure (e.g., ACB + AVR). Coagulation factor deficiency must either be known to exist (as indicated by elevated EXTEM clotting time \[CT\] or international normalized ratio \[INR\]), or be suspected based on the clinical situation.
Exclusion
- Patients who meet any of the following criteria are not eligible for the study:
- Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump \[IABP\]), or repair of thoracoabdominal aneurysm
- Critical state immediately before emergency surgery with high probability of death within 24 hours of surgery (e.g., acute aortic dissection, cardiac arrest within 24 hours before start of surgery)
- History of heparin induced thrombocytopenia
- Last preoperative INR \>1.5 and patient on warfarin
- Taken dabigatran, rivaroxaban, apixaban, or edoxaban within 48 hours of start of surgery
- Administered PCC or FP within 48 hours before start of surgery
- History of severe allergic reaction to PCC or FP
- Refusal of allogeneic blood products due to religious or other reasons
- Known pregnancy
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04114643
Start Date
September 24 2019
End Date
December 31 2020
Last Update
November 3 2020
Active Locations (1)
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1
Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M4N 3M5