Haemorrhage within 24 hours of the start of cardiac surgery Circulatory System
Conditions
Interventions
Cardiac surgery patients who haemorrhage during or within 24 hours of the start of surgery are randomly allocated to receive either the current standard treatment (fresh frozen plasma, FFP, or LG Octa
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Undergoing cardiac surgery (Elective and Urgent procedures) not described in the exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of any of the following new events from 24 hours post-surgery up to 90 days post-surgery: 1. All-cause mortality according to clinical diagnosis 2. Acute respiratory failure according to clinical diagnosis 3. Acute myocardial injury according to clinical diagnosis 4. Acute renal failure requiring renal replacement therapy (excluding dialysis during cardiopulmonary bypass) according to clinical diagnosis 5. Acute liver injury according to clinical diagnosis 6. Acute intestinal injury according to clinical diagnosis 7. Focal neurological deficit according to clinical diagnosis 8. Infection according to clinical diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Individual components of the primary outcome up to 90 days or death, whichever occurs first: 1.1. All-cause mortality according to clinical diagnosis 1.2. Acute respiratory failure according to clinical diagnosis 1.3. Acute myocardial injury according to clinical diagnosis 1.4. Acute renal failure requiring renal replacement therapy (excluding dialysis during cardiopulmonary bypass) according to clinical diagnosis 1.5. Acute liver injury according to clinical diagnosis 1.6. Acute intestinal injury according to clinical diagnosis 1.7. Focal neurological deficit according to clinical diagnosis 1.8. Infection according to clinical diagnosis 2. Clinical evidence of haemostasis defined as: 2.1. Amount of blood loss (in ml) collected in chest drains at 6 hours and 24 hours post end of surgery, taken from clinical notes 2.2. Amount of total allogeneic (in units) blood transfusion (red blood cells, fresh frozen plasma, cryoprecipitate, platelets), total dose of haemostatic factor concentrates (PCC, fibrinogen concentrate, activated recombinant factor VIIa, or any other blood product concentrate) at 24 hours and 7 days from randomisation, taken from clinical notes 2.3. Whether re-exploration for bleeding up to 7 days post end of surgery was required, and whether a surgical point of bleeding was identified, taken from clinical notes 3. Length of stay in hospital, measured in days, up to and including 90 days from randomisation or hospital discharge or death whichever occurs first – i.e. time to discharge from acute care after index hospitalisation; this includes time to discharge from satellite acute care units; taken from clinical notes 4. Duration of mechanical ventilation (in days) during index hospitalisation up to 90 days from randomisation or hospital discharge or death, whichever occurs first, taken from clinical notes 5. Number of hospital re-admissions up to and including 90 days from randomisation, taken from medical records 6. Safety measured through: 6.1. Tran | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactCharlie Brown
Outcome results
None listed