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

NCT06153082 | Recruiting

• 1 other identifier: ILBS-Cirrhosis-69
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Cumulative volume of FFP transfused at Day 5.

  Day 5

Secondary Outcomes (6)

• Cumulative volume of Cryoprecipitate in both groups

  6 weeks

• Cumulative volume of Platelet in both groups

  6 weeks

• Cumulative volume of Trenaxemic acid Transfusion related reactions in both groups

  6 weeks

• Duration of intensive care unit (ICU) in both groups

  6 weeks

• Duration of hospital stay in both groups

  6 weeks

Study Arms (2)

ROTEM Group

EXPERIMENTAL

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 Test: ROTEM

THROMBOELASTOGRAPHY

ACTIVE COMPARATOR

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°

Diagnostic Test: Thromboelastography

Interventions

ROTEM DIAGNOSTIC_TEST

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

ROTEM Group

Thromboelastography DIAGNOSTIC_TEST

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°.

THROMBOELASTOGRAPHY

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Dr Saurav Paul

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Dr Saurav Paul, MD

CONTACT

01146300000; saurav.paul79@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: December 16, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

IN (1)