PROthrombin complex concentrate versus fresh frozen Plasma for bleeding in adults undergoing HEart SurgerY (PROPHESY-2 trial)

Phase 3

• Conditions: Haemorrhage within 24 hours of the start of cardiac surgery; Circulatory System

• Registration Number: ISRCTN92114384
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-16
• Last Update Posted: 27 May 2024
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 496

Inclusion Criteria

1. Age =18 years
2. Undergoing cardiac surgery (Elective and Urgent procedures) not described in the exclusion criteria

Exclusion Criteria

1. Emergency and Salvage procedures (as per definitions in section 6.0)
2. First-time isolated coronary artery bypass graft (CABG) surgery given the low risk of significant bleeding
3. First time isolated aortic valve replacement (excluding active endocarditis)
4. First time isolated mitral valve replacement
5. Surgeries that do not involve cardiopulmonary bypass
6. Heart transplant
7. Use of warfarin within 3 days prior to surgery
8. Use of direct oral anticoagulants (i.e. dabigatran, rivaroxban, apixaban or edoxaban etc) within 48 hours prior to surgery (or 72 hours if patient has renal impairment – i.e. estimated glomerular filtration rate of <30 ml/min)
9. Any contraindication to PCC or FFP or LG-Octaplas, for example: known or suspected allergy to heparin, Sodium citrate dihydrate, sodium dihydrogenphosphate dihydrate and Glycine, History of Heparin-induced thrombocytopenia, history of blood transfusion reaction due to IgA deficiency with known antibodies against IgA
10. Patients refusing blood transfusion for any reason
11. Inherited bleeding disorder (i.e. any inherited clotting factor deficiencies, or platelet disorders)
12. Pregnancy as PCC is contraindicated
13. Documented thrombophilia defects (antiphospholipid syndrome, severe protein S deficiency, antithrombin deficiency)
14. Documented venous thromboembolism in the last 3 months prior to surgery
15. Patients who are expected to require Extracorporeal Membrane Oxygenation after cardiac surgery
16. Patient previously randomised into this trial and has not reached 90 days post randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified