NCT04114643: FARES

Factor Replacement in Surgery

Status unknown Phase 2 Last updated 3 November 2020

What this trial tests

Phase 2 trial testing Prothrombin Complex Concentrate in Bleeding in Cardiac Surgery in 103 participants. Status unknown.

Timeline

24 September 2019

Primary endpoint
21 July 2020

31 December 2020

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	103
Start date	24 September 2019
Primary completion	21 July 2020
Estimated completion	31 December 2020
Sites	1 location across Canada

Drugs / interventions tested

• Prothrombin Complex Concentrate — full drug profile →
• Frozen Plasma — full drug profile →

Conditions studied

• Bleeding in Cardiac Surgery — all drugs for Bleeding in Cardiac Surgery →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Bleeding in Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicentre, randomized, active-control, pragmatic, Phase 2 pilot study in adult cardiac surgery patients. Two Canadian hospitals will participate, and it is estimated that the study will take approximately 9 months to complete.

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transfusion strategies in bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine.
   Vlaar APJ, Dionne JC, de Bruin S, Wijnberge M, et al · · 2021 · cited 65× · PMID 34677620 · DOI 10.1007/s00134-021-06531-x
2. Comparison of 4-Factor Prothrombin Complex Concentrate With Frozen Plasma for Management of Hemorrhage During and After Cardiac Surgery: A Randomized Pilot Trial.
   Karkouti K, Bartoszko J, Grewal D, Bingley C, et al · · 2021 · cited 59× · PMID 33792729 · DOI 10.1001/jamanetworkopen.2021.3936
3. Prothrombin complex concentrate vs. fresh frozen plasma in adult patients undergoing heart surgery - a pilot randomised controlled trial (PROPHESY trial).
   Green L, Roberts N, Cooper J, Agarwal S, et al · · 2021 · cited 39× · PMID 33285008 · DOI 10.1111/anae.15327