Factor concentrates versus Allogeneic blood in CardioThoracic Surgery trial

Phase 3

• Conditions: Cardiac Surgery; Blood transfusion; Surgery - Other surgery; Anaesthesiology - Other anaesthesiology; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12615000315516
• Lead Sponsor: St Vincent's and Mater Health Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

All adult patients, aged 18 and over, presenting for cardiac surgery at St Vincent’s Hospital capable of giving consent, including solid organ transplantation and patients presenting for surgery on the antiplatelet agents aspirin and/or clopidogrel and/or the anticoagulant warfarin.

Exclusion Criteria

Documented haemostatic disease such as Haemophilia or Von Willebrands Disease; Incapable of consent; Surgery to involve placement of a ventricular assist device either left of right sided; Known history of deep venous thrombosis, pulmonary embolism or prothrombotic disorder such as antiphospholipid syndrome; Preoperative use of an antiplatelet agent or anticoagulant other than those allowed in the inclusion criteria, such as a direct thrombin antagonist, eg dabigatran or a different antiplatelet agent such as ticagrelor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary outcome will be red cell transfusion rate (i.e. number of red cell units per hour) and total amount, including rate of avoidance of requirement for transfusion as measured as a comparison of those not requiring transfusion in both the intervention and comparator arms.[Over the course of admission for surgery.]