Short Course Terlipressin for Control of Acute Variceal Bleeding

Aga Khan University

Status and phase: Completed; Phase 4

Conditions: Portal Hypertension; Esophageal Varices; Hemorrhage

Treatments: Drug: Terlipressin & then Dummy; Drug: Terlipressin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00369694

446-Med/ERC-05

Details and patient eligibility

About

The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence can save cost and may decrease length of hospital stay especially in the I.C.U or high dependency units.

Full description

The esophageal variceal bleeding is usually controlled with endoscopic treatment of variceal band ligation or sclerotherapy along with vasoactive drugs like Terlipressin or Octreotide. The risk of re-bleeding is highest during the initial 5 days from first presentation. Terlipressin is usually given for 3 days (72 hours). In this study we are trying to prove that among low to moderate risk patients, a short course of 1 day (24 hours) of Terlipressin is as effective as 3 days (72 hours) in preventing re-bleed once bleeding has been controlled with endoscopic therapy. This intervention will save 2 days cost incurred on the Terlipressin and may also help in decreasing the length of hospital stay in future.

Enrollment: 130 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute esophageal variceal bleed
• Liver cirrhosis
• Child's score </= 11

Exclusion criteria

• Patient on Mechanical ventilator and or ionotropic support
• Active angina, Recent Myocardial infarction or dynamic EKG changes
• Failure to control variceal bleed on initial endoscopy
• Gastric variceal bleed
• Spontaneous bacterial peritonitis at presentation
• Hepatocellular carcinoma or other liver metastatic malignancy
• Portal vein thrombosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

72 hours of Terlipressin

Treatment:

Drug: Terlipressin

2

Placebo Comparator group

Description:

24 hours of Terlipressin \& then next 48 hours of Dummy of Terlipressin

Treatment:

Drug: Terlipressin & then Dummy