Mesenteric IschemiaPhase 4NCT02645240
Predictive Factors of Intestinal Infraction in Acute Mesenteric Ischemia
A Phase 4 study testing Heparin injection in people with Mesenteric Ischemia, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Mesenteric Ischemia
- What is being tested?
- Heparin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acute mesenteric Ischemia
Who cannot join
- Patients with other causes of acute abdomen other than mesenteric Ischemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors of Intestinal Infraction in Patients With Acute Mesenteric Ischemia
The study aims to identify several factors that can accurately predict the incident of intestinal infraction in patients with mesenteric vascular occlusion or ischemia.
Read the 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.
- Conditions
- Mesenteric Ischemia
- Being tested
- Heparin injection
- Medical subject headings
- Mesenteric Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin injectionDrug
Also called Low molecular weight heparin injection
Intravenous heparin injection in patients with acute mesenteric ischemia and evaluating their response within 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Heparin injection | Experimental | Injection of low molecular weight heparin in patients with acute mesenteric ischemia to assess outcome Receives: Drug: Heparin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Number of patients with resolved abdominal symptoms and incidence of patients developing shock
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sameh H Emile, M.D, Principal investigator, Mansoura Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645240
- Sponsor's protocol ID
- mansoura30
- Status last verified
- Aug 2017
- First submitted
- 29 Dec 2015
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Intestinal Infraction in Patients With Acute Mesenteric Ischemia
- ClinicalTrials.gov ID
- NCT02645240
- Acronym / sponsor ID
- mansoura30
- Conditions
- Mesenteric Ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heparin injection | Experimental | Drug: Heparin injectionInjection of low molecular weight heparin in patients with acute mesenteric ischemia to assess outcome |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute mesenteric Ischemia
Key exclusion criteria (1 listed)
- Patients with other causes of acute abdomen other than mesenteric Ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin injectionAlso: Low molecular weight heparin injectionIntravenous heparin injection in patients with acute mesenteric ischemia and evaluating their response within 24 hours | Drug | Heparin injection |
Primary outcome
Clinical improvement
Time frame: 48 hours
Number of patients with resolved abdominal symptoms and incidence of patients developing shock
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: Undecided
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ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery
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Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh H Emile, M.D principal investigator
Mansoura Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin injection in people with Mesenteric Ischemia, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.