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Outcome Measures

Primary Outcomes (1)

Number of Patients Requiring Additional Hemostatic Intervention
Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII \[rFVIIa\], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP.
60 minutes to 24 hours after first dose of IMP

Secondary Outcomes (28)

Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels
60 minutes to 24 hours after first dose of IMP
Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups.
12 and 24 hours after chest closure
Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB).
24 hours after surgery start, after the end of CPB and after IMP initiation
Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups.
First 24 hours after the end of CPB
Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups.
First 24 hours after the end of CPB

Study Arms (2)

Octaplex

EXPERIMENTAL

Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg). Octaplex: Prothrombin complex concentrate

Drug: Octaplex

Frozen plasma

ACTIVE COMPARATOR

Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg). Frozen Plasma Product, Human

Drug: Frozen Plasma Product, Human

Study Sites (13)

Duke University Health System

Durham, North Carolina, 27710, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

University of British Columbia and Vancouver Coastal Health Authority

Vancouver, British Columbia, V5Z 1M9, Canada

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L 8E7, Canada

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

London Health Sciences

Related Publications (3)

Tanaka KA, Butt AL, Stewart KE, Pezeshki G, Werner S, Bartoszko J, Ghadimi K, Solomon C, Vandyck K, Levy JH, Callum JL, Knaub S, Hegener O, Karkouti K. The association of estimated citrate load with frozen plasma versus four-factor prothrombin complex concentrate for coagulopathy after cardiac surgery: a post hoc exploratory analysis of the FARES-II randomised controlled trial. BJA Open. 2026 Jun 29;19:100577. doi: 10.1016/j.bjao.2026.100577. eCollection 2026 Sep.

PMID: 42404094DERIVED

Karkouti K, Callum JL, Bartoszko J, Tanaka KA, Knaub S, Brar S, Ghadimi K, Rochon A, Mullane D, Couture EJ, Lin Y, Harle C, Zeller M, Tran DTT, Solomon C, Rao V, Law M, Butt AL, Chen EP, Martins MR, Saha T, Shih AW, Vezina MC, Moussa F, Pereira Cezar Zamper R, Syed S, Buyukdere H, Werner S, Grewal D, Wong D, Vandyck KB, Tanzola R, Hughes B, Royer O, Wong S, Levy JH; FARES-II Study Group. Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery: The FARES-II Multicenter Randomized Clinical Trial. JAMA. 2025 May 27;333(20):1781-1792. doi: 10.1001/jama.2025.3501.

PMID: 40156829

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, OUTCOMES ASSESSOR

Masking Details

Given the physical differences in the products and the emergency nature of the intervention, attending clinicians present during the infusion of the blood products/components were not blinded to the treatment. To minimize bias, treating clinicians were blinded to group assignments until immediately prior to IMP infusion. The sponsor and data management teams were also blinded to treatment group allocations

Purpose

TREATMENT

Intervention Model

PARALLEL

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (28)

Study Arms (2)

Octaplex

Frozen plasma

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (3)

MeSH Terms

Interventions

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (28)

Study Arms (2)

Octaplex

Frozen plasma

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (3)

MeSH Terms

Interventions

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations