NCT05698134

Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with cirrhosis who meets eligibility criteria will be divided into two groups 1. Those who are undergoing elective procedures will be randomized into 1:1 ratio into either standard of care (institutional transfusion protocol) or ROTEM guided protocol. Baseline ROTEM will be obtained before and after blood product transfusion. 2. Those who are not for elective procedures and does not meet criteria for randomization will be entered into data collection for secondary endpoints analysis. These patients will have baseline ROTEM before transfusion and post transfusion ROTEM in those who require blood prodducts transfusion.

Conditions

• Cirrhosis, Liver

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ROTEM	ROTEM is a commercially available whole blood Viscoelastic-Haemostatic Assay(VHA) point-of-care, global and dynamic haemostasis assessment tests that measures the viscoelastic changes occurring during the haemostatic process. They provide real-time, comprehensive reflection of the interaction between plasma, blood cells and platelets. It display hypo or hyper-coagulable features in patients with cirrhosis. It is widely used prior to cardiac, obstetric, trauma and liver transplant surgery to assess and correct for coagulation defects.
OTHER	Standard of care	Standard of care

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-05-28
• Completion: 2023-05-28
• First posted: 2023-01-26
• Last updated: 2023-01-26

Locations

1 site across 1 country: Singapore