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A study to determine if a new method of testing blood clotting (thromboelastography) can help to predict how much blood transfusion is required in liver disease patients with variceal bleeding.

Thromboelastography guided blood product transfusion in cirrhosis patients with acute variceal bleeding: a Randomized Controlled Trial - TEGVAR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/02/007864
Enrollment
100
Registered
2017-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Cirrhosis with Variceal bleeding

Interventions

Intervention1: Standard therapy arm: FFP and Platelets transfusion as per standard guidelines Control Intervention1: TEG therapy arm: FFP and Platelets transfusion without TEG guided

Sponsors

Department of Gastroenterology AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cirrhosis with acute variceal bleeding 2. Age between 18-65 years 3. Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Variceal bleeding secondary to causes other than cirrhosis. eg, extrahepatic venous obstruction, hepatic venous outflow track obstruction 2. Patients with malignancy/disseminated intravascular coagulation (DIC)/known coagulopathic disorder (haemophilia) apart from cirrhosis. 3. History of intake of platelets inhibitors (eg, aspirin, clopidogrel) and drugs affecting coagulation cascade (eg, vitamin K anatagonists) within past 7 days 4. Pregnant women and those on oral contraceptives 5. Patients with chronic renal failure 6. History of underlying hypercoagulable/ hypocoagulable states eg. paroxysmal nocturnal hemoglobunuria (PNH), polycythemia vera etc 7. Patients receiving blood products (fresh frozen plasma and platelet prior to thromboelastography) 8. Patients with shock 9. Sepsis 10. Acute on chronic liver failure 11. Hepatorenal syndrome 12. Hepatic encephalopathy 13. Contraindication to endoscopy 14. Not willing to provide consent.

Design outcomes

Primary

MeasureTime frame
Reduction in the requirement of blood products between the two groups.Timepoint: 24 hours, 120 hours

Secondary

MeasureTime frame
1. Control of variceal bleeding at 24 hours and 5 days. 2. Rebleeding and mortality at 6 weeks. Timepoint: 1. Control of variceal bleeding at 24 hours and 5 days. 2. Rebleeding and mortality at 6 weeks.

Countries

India

Contacts

Public ContactDr Shalimar

AIIMS, New Delhi

drshalimar@yahoo.com9868397211

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 21, 2026