Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
103 participants
INTERVENTIONAL
2019-09-24
2020-12-31
Brief Summary
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Approximately 120 bleeding adult cardiac surgical patients who require coagulation factor replacement during cardiac surgery will be included. Patients will be randomized to receive either PCC or FP when the blood bank receives the first order for coagulation factor replacement and deems it to be in accordance with accepted clinical standards. Patients will be treated according to their assigned group on the first and second times when coagulation factor replacement is ordered during the treatment period (24 hours after randomization). For any additional doses (i.e., the third dose and thereafter), patients in both groups will receive FP (in 1U increments at the discretion of the ordering physician). No other aspects of care will be modified.
This pilot study aims to select a clinically relevant primary efficacy endpoint for a confirmative Phase 3 study, which will subsequently aim to determine if PCC is non-inferior or superior to FP in terms of effica-cy and safety in bleeding cardiac surgical patients. In the pilot study, safety outcomes will be measured for the first 28 days, which is the duration of participation of each patient in the trial.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Prothrombin Complex Concentrate
Prothrombin Complex Concentrate
Octaplex will be administered when the blood bank receives an order for coagulation factor replacement
Frozen Plasma
Frozen Plasma
Frozen Plasma will be administered when the blood bank receives an order for coagulation factor replacement
Interventions
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Prothrombin Complex Concentrate
Octaplex will be administered when the blood bank receives an order for coagulation factor replacement
Frozen Plasma
Frozen Plasma will be administered when the blood bank receives an order for coagulation factor replacement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Management of bleeding, or
2. Anticipated bleeding in a patient who has
1. been on-pump for \>2 hours, or
2. 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 Criteria
1. Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump \[IABP\]), or repair of thoracoabdominal aneurysm
2. 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)
3. History of heparin induced thrombocytopenia
4. Last preoperative INR \>1.5 and patient on warfarin
5. Taken dabigatran, rivaroxaban, apixaban, or edoxaban within 48 hours of start of surgery
6. Administered PCC or FP within 48 hours before start of surgery
7. History of severe allergic reaction to PCC or FP
8. Refusal of allogeneic blood products due to religious or other reasons
9. Known pregnancy
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Keyvan Karkouti, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Countries
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References
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Hayes K, Fernando MC, Jordan V. Prothrombin complex concentrate in cardiac surgery for the treatment of coagulopathic bleeding. Cochrane Database Syst Rev. 2022 Nov 21;11(11):CD013551. doi: 10.1002/14651858.CD013551.pub2.
Karkouti K, Bartoszko J, Grewal D, Bingley C, Armali C, Carroll J, Hucke HP, Kron A, McCluskey SA, Rao V, Callum J. Comparison of 4-Factor Prothrombin Complex Concentrate With Frozen Plasma for Management of Hemorrhage During and After Cardiac Surgery: A Randomized Pilot Trial. JAMA Netw Open. 2021 Apr 1;4(4):e213936. doi: 10.1001/jamanetworkopen.2021.3936.
Other Identifiers
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19-5393
Identifier Type: -
Identifier Source: org_study_id