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| Name | Class |
|---|---|
| Ferozsons Laboratories Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 72 hours of Terlipressin |
|
| 2 | Placebo Comparator | 24 hours of Terlipressin & then next 48 hours of Dummy of Terlipressin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terlipressin | Drug | 2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variceal Re-bleed | 120 hours (5 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| All cause 30 days mortality | 30 days | |
| 30 days rebleed | 30 days from index bleed | |
| Safety of Terlipressin |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saeed S Hamid, FRCP, FACG | The Aga Khan University Hospital | Study Chair |
| Zahid SM Azam, MBBS, FCPS | The Aga Khan University Hospital | Study Director |
| Wasim SM Jafri, FRCP, FACG | The Aga Khan University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Aga Khan University Hospital | Karachi | Sindh | 74800 | Pakistan |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D004932 | Esophageal and Gastric Varices |
| D006975 | Hypertension, Portal |
| D008551 | Melena |
| D006396 | Hematemesis |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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| Terlipressin & then Dummy | Drug | 2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours. |
|
|
| In Hospital safety |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D014839 | Vomiting |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |