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1 day vs 3 days of terlipressin therapy in cirrhosis patients with variceal bleeding

Comparison of 1-day vs. 3-day intravenous terlipressin in patients with acute variceal bleeding: open-label randomized control trial. - TER1vs3

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021771
Enrollment
200
Registered
2019-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: - Health Condition 2: K74- Fibrosis and cirrhosis of liver

Interventions

Intervention1: Terlipressin-3d arm: Patients will receive intravenous bolus terlipressin for 1 mg every 4 hours from the time of admission, and it will continue for 72 hours. Control Intervention1: Te

Sponsors

Dr Shalimar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. (compensated or decompensated) with acute variceal bleeding 2. 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 tract obstruction 2. Patients with malignancy/disseminated intravascular coagulation (DIC)/known coagulopathic disorder (hemophilia) apart from cirrhosis. 3. History of intake of platelets inhibitors (e.g., aspirin, clopidogrel) and drugs affecting coagulation cascade (e.g., vitamin K antagonists) within the past 7 days 4. Pregnant women 5. Patients with chronic renal failure 6. Patients with shock or requiring mechanical ventilation 7. Sepsis 8. Acute on chronic liver failure 9. Hepatorenal syndrome 10. Hepatic encephalopathy 11. Contraindication to endoscopy 12. Not willing to provide consent 13. Active angina, Recent Myocardial infarction or dynamic EKG changes 14. Failure to control variceal bleed on initial endoscopy 15. Isolated gastric variceal bleeding 16. Spontaneous bacterial peritonitis at presentation 17. Hepatocellular carcinoma or other liver metastatic malignancy

Design outcomes

Primary

MeasureTime frame
1.Control of variceal bleeding at 24 hours and 5-days.Timepoint: 1.Control of variceal bleeding at 24 hours and 5-days.

Secondary

MeasureTime frame
1. Rebleeding and mortality at 6 weeks. 2. Difference in hepatic venous pressure gradient between the 2-groups at 1, 2 and 3 days post endoscopic variceal band ligationTimepoint: 6 weeks

Countries

India

Contacts

Public ContactDr Piyush Pathak

All India Institute of Medical Sciences

drshalimar@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026