350
Participants
Start Date
April 1, 2021
Primary Completion Date
December 31, 2023
Study Completion Date
January 30, 2024
Fibrinogen + PCC
"Patients randomized to the intervention group will receive 4g of Fibryga and 2000 IU Octaplex will be released as part of the first and second MHP packs, if requested.~If a third MHP pack is required, and thereafter, FC will be administered if the fibrinogen level drops below 1.5-2.0 g/L at the discretion of the clinical team or based on conventional laboratory test results or viscoelastic methods.~Patients in both groups will otherwise receive identical MHP treatment packs (4 units of red blood cells \[RBC\] in pack 1 and 4 units of RBC and 1 pool of platelets in pack 2 (equivalent to 4 units)."
Frozen Plasma
"4U FP will be released as part of the first and second MHP packs.~Patients in both groups will otherwise receive identical MHP treatment packs (4 units of red blood cells \[RBC\] in pack 1 and 4 units of RBC and 1 pool of platelets in pack 2 (equivalent to 4 units).~Patients randomized to the control group may receive FC if the fibrinogen level drops below 1.5-2.0 g/L at the discretion of the clinical team or based on conventional laboratory test results or viscoelastic methods. FC dosing in MHP packs 3 and above will be site-specific and at the discretion of the treating clinician."
RECRUITING
Vancouver General Hospital, Vancouver
RECRUITING
Hamilton Health Sciences and McMaster University, Hamitlon
RECRUITING
Kingston Health Sciences Centre, Kingston
RECRUITING
Victoria Hospital, London
RECRUITING
Sunnybrook Health Sciences Centre, Toronto
RECRUITING
St. Michael's Hospital, Toronto
Collaborators (1)
Sunnybrook Health Sciences Centre
OTHER
Octapharma
INDUSTRY
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Canadian Institute for Military and Veteran Health Research Defense Research & Development Canada
UNKNOWN
University Health Network, Toronto
OTHER