Factor In the Initial Resuscitation of Severe Trauma 2 Patients

PHASE4UnknownINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

April 1, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

January 30, 2024

Conditions
Traumatic HemorrhageCoagulopathyMassive Hemorrhage
Interventions
BIOLOGICAL

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)."

BIOLOGICAL

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."

Trial Locations (6)

V5Z 4E3

RECRUITING

Vancouver General Hospital, Vancouver

L8L 2X2

RECRUITING

Hamilton Health Sciences and McMaster University, Hamitlon

K7L 2V7

RECRUITING

Kingston Health Sciences Centre, Kingston

N6A 5W9

RECRUITING

Victoria Hospital, London

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

Unknown

RECRUITING

St. Michael's Hospital, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sunnybrook Health Sciences Centre

OTHER

collaborator

Octapharma

INDUSTRY

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Canadian Institute for Military and Veteran Health Research Defense Research & Development Canada

UNKNOWN

lead

University Health Network, Toronto

OTHER

NCT04534751 - Factor In the Initial Resuscitation of Severe Trauma 2 Patients | Biotech Hunter | Biotech Hunter