Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding.
Recruiting
N/AInterventional Study
Liver Cirrhosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Institute of Liver and Biliary Sciences, India · Other
Who this trial is looking for
This trial is looking for adults with liver cirrhosis who are experiencing bleeding from a non-variceal source. Participants will be divided into two groups to compare different methods of correcting blood clotting issues and receiving blood products.
Are You a Good Fit for This Trial?
You may be able to join if
I have liver cirrhosis.
I am between 18 and 80 years old.
I have non-variceal upper GI bleeding.
I have significant coagulopathy with INR > 1.8 and/or low platelet count.
You may not be able to join if
I have bleeding from varices.
I have a post-variceal ligation ulcer bleed.
I have had a blood clot in a vein or artery.
I am on anti-platelet or anticoagulant therapy.
I am pregnant.
I have significant heart or lung diseases.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 tr…
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.
Trial Locations
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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 …
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.
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