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Recruitment was severely affected due to COVID, so study was stopped prematurely.
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| University of Florida Health | OTHER |
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This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.
In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices.
Octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. The recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs.
This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24-hour octreotide infusion | Experimental | Patients will receive octreotide infusion over 24 hours |
|
| 72-hour octreotide infusion | Active Comparator | Patients will receive octreotide infusion over 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide | Drug | Octreotide infusion for 24-hours in patients with bleeding esophageal varices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed | Rebleeding within 72-hours will be defined as any of the following:
| 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed | Rebleeding after 72-hours will be defined as:
| 7 days and 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Rockey, M.D | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Health | Jacksonville | Florida | 32209 | United States | ||
| University of Illinois at Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39241828 | Result | Allam J, De Melo S, Feagins LA, Agrawal D, Malespin M, Shuja A, Lara LF, Rockey DC. Comparison of 24 vs 72-hr octreotide infusion in acute esophageal variceal hemorrhage - A multi-center, randomized clinical trial. Am J Med Sci. 2025 Jan;369(1):71-76. doi: 10.1016/j.amjms.2024.08.027. Epub 2024 Sep 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 24-hour octreotide infusion | Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices. |
| FG001 | 72-hour octreotide infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2019 |
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| Survival at 7 Days and 30 Days After Control of Initial Bleed | Survival at 7 days and 30 days. | 7 days and 30 days |
| Chicago |
| Illinois |
| 60607 |
| United States |
| The Ohio state University | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| The University of Texas at Austin | Austin | Texas | 78712 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Brooke Army Medical Center | Houston | Texas | 78234 | United States |
Patients will receive octreotide infusion over 72 hours
Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 24-hour Octreotide Infusion | Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices. |
| BG001 | 72-hour Octreotide Infusion | Patients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed | Rebleeding within 72-hours will be defined as any of the following:
| Posted | Count of Participants | Participants | 72 hours |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed | Rebleeding after 72-hours will be defined as:
| Posted | Count of Participants | Participants | 7 days and 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Survival at 7 Days and 30 Days After Control of Initial Bleed | Survival at 7 days and 30 days. | Posted | Count of Participants | Participants | 7 days and 30 days |
|
|
up to 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 24-hour octreotide infusion | Patients will receive octreotide infusion over 24 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices. | 0 | 15 | 0 | 15 | 2 | 15 |
| EG001 | 72-hour octreotide infusion | Patients will receive octreotide infusion over 72 hours Octreotide: Octreotide infusion for 24-hours in patients with bleeding esophageal varices. | 1 | 19 | 1 | 19 | 8 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death (Sepsis) | General disorders | Systematic Assessment | Sepsis |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Dysphagia/Odynophagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nasogastric Tube Insertion | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mechanical Ventilation >12h | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Vasopressor Use | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Don Rockey | Medical University of South Carolina | (843) 792-6982 | rockey@musc.edu |
| Nov 4, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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|
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