None listed
Conditions
Brief 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.
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 = ((
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.
Sponsors
St Vincent's and Mater Health Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed