Short Course Terlipressin for Control of Acute Variceal Bleeding

Hemorrhage Clinical Trial

Official title:

Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369694
• Other study ID #: 446-Med/ERC-05
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2006
• Last updated: September 24, 2008
• Start date: August 2006
• Est. completion date: August 2008

Study information

• Verified date: September 2008
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Varices
• Hemorrhage
• Hypertension, Portal
• Portal Hypertension

Intervention

Drug:
• Terlipressin
2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
• Terlipressin & then Dummy
2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.

Locations

Country	Name	City	State
Pakistan	The Aga Khan University Hospital	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	Ferozsons Laboratories Ltd.

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variceal Re-bleed		120 hours (5 Days)	Yes
Secondary	All cause 30 days mortality		30 days	No
Secondary	30 days rebleed		30 days from index bleed	No
Secondary	Safety of Terlipressin		In Hospital safety	Yes