Comparisons of two different blood products (callled fresh frozen plasma and prothrombin complex concentrate) in patients who are undergoing cardiac surgery and who develop major bleeding that requires treatment with blood product - a pilot randomised control trial.

Phase 1

• Conditions: Major bleeding during cardiac surgery not related to vitamin K antagonists; MedDRA version: 20.1Level: LLTClassification code 10051536Term: Intraoperative bleedingSystem Organ Class: 100000004863; MedDRA version: 20.1Level: LLTClassification code 10036277Term: Postoperative bleedingSystem Organ Class: 100000004863; MedDRA version: 21.1Level: PTClassification code 10042609Term: SurgerySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2018-003041-41-GB
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-18
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Age =18 years
- Able to give consent
- Any cardiovascular surgeries excluding procedures under exclusion criteria

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

A participant is not eligible if any of the following criteria are met:
- 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 three days
- Use of direct oral anticoagulants (i.e. dabigaran, rivaroxban, 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 LG-octaplas, or PCC
- Known or suspected allergy to heparin, Sodium citrate dihydrate, sodium
dihydrogenphosphate dihydrate and Glycine
- History of Heparin-induced thrombocytopenia
- Individuals who have IgA deficiency with known antibodies against IgA
- Documented venous thromboembolism in the last three months
- Documented antiphospholipid syndrome
- Severe Protein S deficiency
- Patients who are likely to go on Extracorporeal Membrane Oxygenation (ECMO) after cardiac surgery
- Any other reasons the investigator may consider the patient to be ineligible for the study
- Participation in another clinical trial, where the patient has received IMP in the last 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified