Not Yet RecruitingPhase 3Phase 4ACTRN12615000315516

Factor concentrates versus Allogeneic blood in CardioThoracic Surgery trial

The influence of factor concentrates in comparison to allogeneic blood for haemostatic resuscitation in cardiac surgery on red cell transfusion rate and associated perioperative morbidities.

Sponsor

St Vincent's and Mater Health Sydney

Enrollment

140 participants

Start Date

May 2, 2016

Study Type

Interventional

Conditions

Cardiac Surgery

Summary

The aims of our study are to determine whether the use of algorithms with point of care testing to guide the use of factor concentrates can target bleeding more quickly and precisely and lead to a reduction in red cell transfusion rates compared to the use of allogeneic blood products. We will also examine its impact on other secondary outcomes, such as morbidity and mortality, bleeding and thrombotic complications.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

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.

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Interventions

The intervention arm will consist of haemostatic resuscitation comprising the use of factor concentrates, specifically a prothrombin complex concentrate (Prothrombinex-VF) and fibrinogen concentrate (RiaSTAP) titrated to point of care viscoelastic testing. Haemostatic therapy will applied when there is clinically documented bleeding (either >60g net weight intraoperatively or >100ml/hr mediastinal drain blood loss) and dosed according to the formulae 1. Fibrinogen concentrate (RiaSTAP) dose = ((12-A10 on FibTEM assay) x body weight)/140 and 2. Prothrombin concentrate in aliquots of 15U/kg if the clotting time (CT) on the ROTEM ExTEM is >90seconds or HepTEM is >240seconds. Both intervention and comparator arms will receive platelet transfusion is there is clinical bleeding and the absolute platelet count is <100 x10^9 or there is a qualitative defect documented on Multiple electrode aggregometry ADPtest, TRAPtest or ASPItest assays.