None listed
Conditions
Brief summary
The aim of this project is to examine the role of a ‘global’ coagulation assay called Rotational Thromboelastometry (ROTEM) in the guidance of prophylactic blood product in patients with liver cirrhosis undergoing invasive procedures. Currently available laboratory tests (such as platelet count, International Normalised Ratio (INR) and activated partial thromboplastin time (aPTT)) are suboptimal for the assessment of bleeding risk in patients with chronic liver disease. These tests may overestimate the risk of bleeding, and their use may result in unnecessary transfusion of blood and coagulation products, exposing the patients to risk of serious adverse events and potentially overuse of scarce blood products. During the past few years, ‘global’ coagulation tests such as ROTEM have been developed to provide an overall measurement of the clotting system. These point of care tests provide quick results and have been used to assess coagulation and better guide blood product transfusion in a number of surgical and trauma multi-transfusion settings. However, the value of these global tests in predicting bleeding outcomes and guiding blood component transfusion in liver disease has not been well studied. We plan a multi-centre randomised-controlled trial (RCT) examining ROTEM-based decisions to guide FFP and platelet use in patients with cirrhosis undergoing invasive procedures. We hypothesise that using ROTEM to guide blood product delivery in this setting, will lead to reduced usage of blood products whilst maintaining optimal clinical outcomes.
Interventions
Patients in the ROTEM arm will receive blood product prophylaxis according to ROTEM cut-offs based on recommendations from surgical and trauma guidelines:
If EXTEM CT > 80 seconds, and no cryoprecipitate indicated: Transfuse FFP 10-15ml/kg
If EXTEM CT > 80 seconds and cryoprecipitate also indicated: Transfuse 1 unit FFP
If EXTEM A5 <35mm and FIBTEM A5 = 9mm: Transfuse 1-2 bags platelets
If EXTEM A5 <35mm and FIBTEM A5 < 9mm: Transfuse one dose cryoprecipitate
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Males and females aged 18 years or older -Cirrhosis -Planned for an invasive procedure -Coagulopathic on the basis of conventional coagulation tests -Able to give informed consent
Exclusion criteria
-Persons under 18 years of age -Inability or unwillingness to give informed consent -Coagulation disorders (other than those relating to liver disease) -Patients on anticoagulant medications (e.g. warfarin, enoxaparin, rivaroxaban, dabigatran, apixiban). -Patients on anti-platelet aggregation agents other than aspirin (eg. clopidogrel, ticagrelor) -Patients in whom it is difficult to obtain blood samples due to venous access difficulties -Active malignancy -Patients who have received FFP, platelet transfusion, cryoprecipitate in the week prior - Patients with stage 4 or 5 chronic kidney disease -Patients receiving renal replacement therapy -Patients with active sepsis
Outcome results
None listed