Trial of PCC Versus FFP in Patients Undergoing Heart Surgery

• Status: Completed
• Trial end date: 2020-01-29
• Target enrollment: 0
• Participant gender: All

Summary

The PROPHESY trial is a single centre pilot trial investigating Fresh Frozen Plasma (FFP) or Prothrombin Complex Concentrate (PCC) treatment for patients who are bleeding during cardiac surgery, and who are NOT receiving a vitamin K antagonist agent (e.g. warfarin).

This pilot study will investigate the feasibility of delivering the different components of the trial, so that investigators can determine if it's feasible to move to a future large trial that will aim to compare the efficacy and safety of FFP versus PCC in adult patients who are actively bleeding during cardiac surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen Mary University of London
• Collaborator: British Heart Foundation
• Treatments: Thrombin

Criteria

Inclusion Criteria:

• Age ≥18 years

• Able to give consent

• Any cardiovascular surgeries excluding procedures under exclusion criteria

Exclusion Criteria:

• Unable to consent

• Patients refusing blood transfusion for any reason

• First time isolated coronary artery bypass grafts (CABG)

• First time isolated aortic valve replacement (excluding active endocarditis)

• Thoraco-abdominal surgeries

• Minor surgeries that do not involve cardiopulmonary bypass

• Use of warfarin within four days

• Use of direct oral anticoagulants (i.e. dabigatran, rivaroxaban, apixaban or edoxaban) within 48 hrs (or 72 hours if patient has renal impairment - i.e. estimated glomerular filtration rate of <30ml/min)

• Inherited bleeding disorder (i.e. any inherited clotting factor deficiencies, or platelet disorders)

• Pregnancy

• Known or suspected allergy to FFP or PCC

• Known or suspected allergy to heparin, Sodium citrate dihydrate, sodium dihydrogenphosphate dihydrate and Glycine

• History of Heparin-induced thrombocytopenia

• Individuals who have Immunoglobulin A (IgA) deficiency with known antibodies against IgA

• Documented venous thromboembolism in the last three months

• Documented antiphospholipid syndrome

• Severe protein S deficiency

• Participation in another clinical trial, where the patient has received Investigational Medicinal Product in the last 3 months