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Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood products used in cirrhosis with Non-variceal Bleeding

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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060804
Enrollment
80
Registered
2023-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: ROTEM Group: 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 EXTEM35 and MCF FIBTEM 8 Pl
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° Duration: Till the bleeding episodes stops

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion 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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Cumulative volume of FFP transfused at Day 5.Timepoint: Day 5.

Secondary

MeasureTime frame
Cumulative volume of Cryoprecipitate, Platelet and Trenaxemic acid Transfusion related reactions Timepoint: Week 6;Duration of intensive care unit (ICU) and hospital stay; and Survival at 6 weeks Timepoint: Week 6

Countries

India

Contacts

Public ContactDr Manoj Kumar Sharma

Institute of Liver and Biliary Sciences

manojkumardm@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026