None listed
Conditions
Brief summary
Routine coagulation studies, such as INR and platelet count, do not accurately reflect the risk of bleeding in chronic liver disease (CLD) patients due to the complex changes in the coagulation system that occurs in CLD. Subsequently, the use of blood products in this setting is resource intensive and not evidence based. It is suggested that rotational thromboelastometry (ROTEM), can predict the risk of thrombosis and bleeding in CLD. The aim of this proposal is to study the effects of a ROTEM-guided blood product protocol in patients with CLD undergoing interventional procedures associated with a moderate to high risk of bleeding. Patients randomized to the ROTEM arm will receive blood products guided by the ROTEM algorithm, developed for the trial, prior to their invasive procedure. Blood products used will be compared to those used in the standard of care arm at each of the participating sites. It is anticipated that the study will show a significant reduction in blood product usage associated with the ROTEM arm. It is hoped that findings from this study will help establish improved evidence based guidelines for patients with CLD undergoing invasive procedures.
Interventions
Patients randomized to the ROTEM arm will receive blood products guided by the ROTEM algorithm prior to their invasive procedure. 3.5ml of blood is to be collected into a citrate tube, which will be processed in the ROTEM analyzer on the same day of the procedure. Only one sample is required. Patients will then receive blood products as per the ROTEM algorithm.
As per the ROTEM algorithm patients will receive FFP, cryoprecipitate, platelets or no blood products based on the ROTEM EXTEM Clottin
Patients randomized to the ROTEM arm will receive blood products guided by the ROTEM algorithm prior to their invasive procedure. 3.5ml of blood is to be collected into a citrate tube, which will be processed in the ROTEM analyzer on the same day of the procedure. Only one sample is required. Patients will then receive blood products as per the ROTEM algorithm. As per the ROTEM algorithm patients will receive FFP, cryoprecipitate, platelets or no blood products based on the ROTEM EXTEM Clotting Time (CT), EXTEM (i.e. assessment of clot formation, fibrin polymerisation and fibrinolysis via the extrinsic pathway) amplitude at 10 minutes (A10) and FIBTEM (i.e. qualitative assessment of fibrinogen status) A10. The blood products given in the ROTEM arms will be compared to those used in the standard of care arm at each of the participating sites. The interventions and patient care will be performed by the usual clinical teams, with aspects of the study (ROTEM measurement, blood product utilization supervised by the Principle Investigator at each site)
Sponsors
Flinders Medical Centre
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
Aged greater than or equal to 18 years Able to give informed consent Patients with coagulopathy (INR greater than or equal to 1.8 OR Platelet count less than or equal to 50,000) who require procedures with moderate to high risk of bleeding
Exclusion criteria
Known overt encephalopathy or cognitive impairment from other aetiologies Non-English speakers
Outcome results
None listed