Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

November 30, 2022

Primary Completion Date

June 27, 2024

Study Completion Date

June 27, 2024

Conditions
Bleeding Cardiac Surgery Patients
Interventions
DRUG

Octaplex

Prothrombin complex concentrate

DRUG

Frozen Plasma Product, Human

If additional treatment is required after the maximum dose of IMP is administered or the treatment period has elapsed, patients in both groups will receive frozen plasma

Trial Locations (13)

27710

Duke University Health System, Durham

73104

University of Oklahoma Health Sciences Center, Oklahoma City

V3L 3W7

Royal Columbian Hospital, New Westminster

V5Z 1M9

University of British Columbia and Vancouver Coastal Health Authority, Vancouver

L8L 8E7

Hamilton Health Sciences Corporation, Hamilton

K7L 2V7

Kingston General Hospital, Kingston

N6A 5A5

London Health Sciences, London

K1Y 4W7

University of Ottawa Heart Institute, Ottawa

M4N 3M5

Sunnybrook Hospital, Toronto

M5B 1W8

St. Michael's Hospital, Toronto

M5G 2C4

Toronto General Hospital, Toronto

H1T 1C8

Montreal Heart Institute, Montreal

G1V 4G5

Quebec Laval, Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY

NCT05523297 - Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery | Biotech Hunter | Biotech Hunter