Interventional Recruiting
NCT05698134 on ClinicalTrials.gov
Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
- Sponsor: Changi General Hospital
- Enrollment: 74 (Estimated)
- Study start: 2021-08-01 (Actual)
- Primary completion: 2023-05-28 (Estimated)
- Study completion: 2023-05-28 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Participants will be randomized into two parallel groups: First group will receive standard of care based on institutional protocol for blood product transfusion Second group will receive ROTEM guided protocol for blood product transfusion
- Masking: Double (Participant, Care Provider)
- PrimaryPurpose: Treatment
Brief Summary
REDuCe is designed to evaluate the role of ROTEM™ in determining the need and the amount of pre-emptive blood products use in patients with cirrhosis undergoing elective procedures compared to the current standard of care. The secondary aim of this study is to evaluate ROTEM™ parameters in patients with acute decompensation, acute on chronic liver failure and acute liver failure and to co-relate it with the conventional coagulation tests.
Conditions
- Cirrhosis, Liver
Intervention / Treatment
- Diagnostic Test: ROTEM
- Other: Standard of care
Primary Outcome Measures
-
Difference in amount of blood products transfused
(24 months)
The difference in amount/volume of blood products used(fresh frozen plasma in mls, cryoprecipitate in units and platelets in units) used in patients with cirrhosis undergoing elective procedure.
Countries
Singapore
Locations and Investigators
-
Changi General Hospital, Singapore, Singapore (Recruiting)
- Rahul Kumar, MBBS
- Rahul Kumar, MBBS (Principal Investigator)
- Chin Kimg Tan, MD