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Recruiting NCT06153082

NCT06153082 Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding.

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Clinical Trial Summary
NCT ID NCT06153082
Status Recruiting
Phase
Sponsor Institute of Liver and Biliary Sciences, India
Condition Liver Cirrhosis
Study Type INTERVENTIONAL
Enrollment 80 participants
Start Date 2023-12-16
Primary Completion 2024-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
ROTEMThromboelastography

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 80 participants in total. It began in 2023-12-16 with a primary completion date of 2024-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study is aim to compare ROTEM and TEG guided coagulopathy correction in cirrhosis with non- variceal bleed.There are no other study in literature to compare this two group in cirrhosis with non-variceal bleed.This study will also assess the volume of blood product transfused with this two groups and it will compare among two groups.This will lessen the blood product transfusion and risk of transfusion relatedated complication.

Eligibility 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.

Contact & Investigator

Central Contact

Dr Saurav Paul, MD

✉ saurav.paul79@gmail.com

📞 01146300000

Frequently Asked Questions

Who can join the NCT06153082 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06153082 currently recruiting?

Yes, NCT06153082 is actively recruiting participants. Contact the research team at saurav.paul79@gmail.com for enrollment information.

Where is the NCT06153082 trial being conducted?

This trial is being conducted at New Delhi, India.

Who is sponsoring the NCT06153082 clinical trial?

NCT06153082 is sponsored by Institute of Liver and Biliary Sciences, India. The trial plans to enroll 80 participants.

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