Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT00369694
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2006-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Course Terlipressin for Control of Acute Variceal Bleeding
Sponsor:
Aga Khan University
Organization:
Study Overview
Official Title:
Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: