Terlipressin Infusion in Variceal Hemorrhage

• Status: Unknown status
• Trial end date: 2020-10-25
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, open label study of intravenous terlipressin infusion vs. bolus for the treatment of variceal hemorrhage. 24 hour regimen consisting of intravenous terlipressin will be used either at a rate of 0.5mg/hour or 2mg bolus every 4 hourly. Participants will be randomized into intervention and control arm using block randomization by computer generated random numbers. Efficacy will be assessed by clinical improvement in symptoms and signs of GI bleed. To assess safety, frequency and degree of adverse reactions will be observed. Periodic assessments until 5 days will be done consisting of physical examination, safety assessments, vital signs and lab tests.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Collaborator: Mallinckrodt
• Treatments: Terlipressin

Criteria

Inclusion Criteria:

1. Age between 18 to 60 years

2. Either gender

3. A diagnosis of liver cirrhosis;

4. Initial presentation with acute gastroesophageal variceal bleeding

5. Willing to provide informed consent to participate in the study (by study subject or next of kin)

Exclusion Criteria:

1. Age < 18 or > 60 years

2. Not willing to provide consent due to any reason

3. No liver cirrhosis

4. Acute upper gastrointestinal bleeding unrelated to varices;

5. Use of somatostatin or octreotide.

6. Hepatocellular Carcinoma (HCC)outside Milan's criteria

7. Advance cardiovascular, pulmonary or renal disease (e.g. asthma, hypertension, arrhythmia, renal insufficiency)

8. History of hypersensitivity to Terlipressin

9. Pregnancy

10. Patients already admitted at AKUH who develop upper GI bleed during admission.