Back to resultsPredictive Factors of Intestinal Infraction in Acute Mesenteric Ischemia
Primary Purpose
Mesenteric Ischemia
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Heparin injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Mesenteric Ischemia
Eligibility Criteria
Inclusion Criteria:
- Patients with acute mesenteric Ischemia
Exclusion Criteria:
- Patients with other causes of acute abdomen other than mesenteric Ischemia
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heparin injection
Arm Description
Injection of low molecular weight heparin in patients with acute mesenteric ischemia to assess outcome
Outcomes
Primary Outcome Measures
Clinical improvement
Number of patients with resolved abdominal symptoms and incidence of patients developing shock
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02645240
Brief Title
Predictive Factors of Intestinal Infraction in Acute Mesenteric Ischemia
Official Title
Predictive Factors of Intestinal Infraction in Patients With Acute Mesenteric Ischemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study aims to identify several factors that can accurately predict the incident of intestinal infraction in patients with mesenteric vascular occlusion or ischemia.
Detailed Description
The study aims to identify several clinical, laboratory, and radiologic factors that can accurately predict the occurrence of intestinal infraction in patients with mesenteric vascular occlusion or ischemia in order to prevent unnecessary surgical intervention in patients with just intestinal ischemia and to hasten intervention in patients with actual intestinal gangrene.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenteric Ischemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heparin injection
Arm Type
Experimental
Arm Description
Injection of low molecular weight heparin in patients with acute mesenteric ischemia to assess outcome
Intervention Type
Drug
Intervention Name(s)
Heparin injection
Other Intervention Name(s)
Low molecular weight heparin injection
Intervention Description
Intravenous heparin injection in patients with acute mesenteric ischemia and evaluating their response within 24 hours
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Number of patients with resolved abdominal symptoms and incidence of patients developing shock
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with acute mesenteric Ischemia
Exclusion Criteria:
Patients with other causes of acute abdomen other than mesenteric Ischemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D
Organizational Affiliation
Mansoura Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Predictive Factors of Intestinal Infraction in Acute Mesenteric Ischemia
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