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Trial record 9 of 9 for:
"Hematemesis"
Short Course Terlipressin for Control of Acute Variceal Bleeding
This study has been completed.
Sponsor:
Aga Khan University
Collaborator:
Ferozsons Laboratories Ltd.
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00369694
First received: August 24, 2006
Last updated: September 24, 2008
Last verified: September 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hemorrhage Esophageal Varices Portal Hypertension | Drug: Terlipressin Drug: Terlipressin & then Dummy | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed |
Resource links provided by NLM:
Further study details as provided by Aga Khan University:
Primary Outcome Measures:
- Variceal Re-bleed [ Time Frame: 120 hours (5 Days) ]
Secondary Outcome Measures:
- All cause 30 days mortality [ Time Frame: 30 days ]
- 30 days rebleed [ Time Frame: 30 days from index bleed ]
- Safety of Terlipressin [ Time Frame: In Hospital safety ]
| Enrollment: | 130 |
| Study Start Date: | August 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
72 hours of Terlipressin
|
Drug: Terlipressin
2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
Other Name: Novapressin
|
|
Placebo Comparator: 2
24 hours of Terlipressin & then next 48 hours of Dummy of Terlipressin
|
Drug: 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.
Other Name: Novapressin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00369694
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369694
Locations
| Pakistan | |
| The Aga Khan University Hospital | |
| Karachi, Sindh, Pakistan, 74800 | |
Sponsors and Collaborators
Aga Khan University
Ferozsons Laboratories Ltd.
Investigators
| Study Chair: | Saeed S Hamid, FRCP, FACG | The Aga Khan University Hospital |
| Study Director: | Zahid SM Azam, MBBS, FCPS | The Aga Khan University Hospital |
| Study Director: | Wasim SM Jafri, FRCP, FACG | The Aga Khan University Hospital |
More Information
| Responsible Party: | Ethical Review Committee (ERC), The Aga Khan University |
| ClinicalTrials.gov Identifier: | NCT00369694 History of Changes |
| Other Study ID Numbers: |
446-Med/ERC-05 |
| Study First Received: | August 24, 2006 |
| Last Updated: | September 24, 2008 |
Keywords provided by Aga Khan University:
|
Esophageal varices Portal Hypertension Melena Hematemesis |
Gastrointestinal Hemorrhage Terlipressin Efficacy Safety |
Additional relevant MeSH terms:
|
Hypertension Hemorrhage Hypertension, Portal Esophageal and Gastric Varices Vascular Diseases Cardiovascular Diseases Pathologic Processes Liver Diseases Digestive System Diseases Esophageal Diseases |
Gastrointestinal Diseases Terlipressin Lypressin Antihypertensive Agents Vasoconstrictor Agents Hemostatics Coagulants Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 14, 2017