Status:
UNKNOWN
Terlipressin Infusion in Variceal Hemorrhage
Lead Sponsor:
Aga Khan University
Collaborating Sponsors:
Mallinckrodt
Conditions:
Terlipressin Adverse Reaction
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 ra...
Detailed Description
Randomized, open label trial, conducted on patients admitted with acute variceal hemorrhage at The Aga Khan University Hospital, Karachi (AKUH). Patients will be followed in clinic after discharge to ...
Eligibility Criteria
Inclusion
- Age between 18 to 60 years
- Either gender
- A diagnosis of liver cirrhosis;
- Initial presentation with acute gastroesophageal variceal bleeding
- Willing to provide informed consent to participate in the study (by study subject or next of kin)
Exclusion
- Age \< 18 or \> 60 years
- Not willing to provide consent due to any reason
- No liver cirrhosis
- Acute upper gastrointestinal bleeding unrelated to varices;
- Use of somatostatin or octreotide.
- Hepatocellular Carcinoma (HCC)outside Milan's criteria
- Advance cardiovascular, pulmonary or renal disease (e.g. asthma, hypertension, arrhythmia, renal insufficiency)
- History of hypersensitivity to Terlipressin
- Pregnancy
- Patients already admitted at AKUH who develop upper GI bleed during admission.
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 25 2020
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04028505
Start Date
October 25 2018
End Date
October 25 2020
Last Update
July 22 2019
Active Locations (1)
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1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74000