RecruitingNot ApplicableNCT06153082

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

Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Nonvariceal Bleeding: A Randomized Controlled Trial

Sponsor

Institute of Liver and Biliary Sciences, India

Enrollment

80 participants

Start Date

Dec 16, 2023

Study Type

INTERVENTIONAL

Conditions

Liver Cirrhosis

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

Patients with Cirrhosis of any etiology
Age between 18 and 80 years;
Presenting with nonvariceal upper GI bleeding (diagnosed after doing upper GI endoscopy, which showed ongoing
bleed form a nonvariceal source); and
Significant coagulopathy assessed by CCTs (INR > 1.8 and/or PLTs < 50 × 109/L).

Exclusion Criteria6

Variceal bleed
Post Variceal ligation ulcer bleed
Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel;
Anti-PLT or anticoagulant therapy at the time of enrollment or that had been discontinued less than 7 days before evaluation for the study;
Pregnancy
Significant cardiopulmonary diseases.

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Interventions

DIAGNOSTIC_TESTROTEM

In ROTEM group if CT EXTEM \>80S FFP at dose of 10ml/kg or PCC 20-25IU/kg ,if MCF EXTEM \<35 and MCF FIBTEM \<8 CRYO or Fibrinogen concentrate, if MCF EXTEM\<35 and MCF FIBTEM \>8 Platelet, CL LY\>50 Trenaxemic acid

DIAGNOSTIC_TESTThromboelastography

Patients in the TEG group received blood components using the following triggers: FFP at a dose of 10 mL/kg of ideal body weight when reaction time (R time) was greater than 10 minutes; a single-donor apheresis platelet (SDAP) unit, which corresponds to approximately 6 to 8 pooled units of PLTs, transfused when the maximum amplitude (MA) was less than 55 mm; and cryoprecipitate (5 pooled units) transfused when the alpha angle was less than 45°.