Comparing ROTEM and TEG for Blood Transfusion in Liver Cirrhosis Patients with Bleeding
Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Nonvariceal Bleeding: A Randomized Controlled Trial
This study is testing whether using ROTEM or TEG can help doctors decide the best blood products to give to liver cirrhosis patients who are bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT06153082 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Rotational Thromboelastometry (ROTEM) and Thromboelastography (TEG) in guiding blood component transfusions for patients suffering from liver cirrhosis with non-variceal bleeding. Patients will be randomly assigned to either the ROTEM or TEG group, where specific blood products will be administered based on defined coagulation parameters. The study will assess the volume of blood products transfused and the associated risks of transfusion-related complications. This is a novel approach as no prior studies have directly compared these two methods in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with liver cirrhosis presenting with non-variceal upper gastrointestinal bleeding and significant coagulopathy.
Not a fit: Patients with variceal bleeding, significant cardiopulmonary diseases, or those on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective management of bleeding in liver cirrhosis patients, reducing the need for blood transfusions and associated complications.
How similar studies have performed: This approach is novel and has not been previously tested in the literature for this specific patient group.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with Cirrhosis of any etiology 2. Age between 18 and 80 years; 3. Presenting with nonvariceal upper GI bleeding (diagnosed after doing upper GI endoscopy, which showed ongoing 4. bleed form a nonvariceal source); and 5. Significant coagulopathy assessed by CCTs (INR \> 1.8 and/or PLTs \< 50 × 109/L). Exclusion Criteria: 1. Variceal bleed 2. Post Variceal ligation ulcer bleed 3. Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel; 4. Anti-PLT or anticoagulant therapy at the time of enrollment or that had been discontinued less than 7 days before evaluation for the study; 5. Pregnancy 6. Significant cardiopulmonary diseases.
Where this trial is running
New Delhi, National Capital Territory of Delhi
- Dr Saurav Paul — New Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Study coordinator: Dr Saurav Paul, MD
- Email: saurav.paul79@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.