Acute Mesenteric IschemiaNCT05706012
Antithrombotic Management of Acute Mesenteric Ischaemia
An observational study of Acute Mesenteric Ischemia and Short Bowel Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Guidelines on the acute and long-term pharmacological treatment of acute mesenteric ischaemia (AMI) recommend the use of thrombolytic, antiplatelet or anticoagulant therapy depending on the aetiology of AMI and the use of stenting but only few details are given on the choice of the drug, dose and duration of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Mesenteric Ischemia, Short Bowel Syndrome
- What is being tested?
- Survey
- How many people
- 51 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2023to 29 Feb 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: international gastro-enterologists an cardiologists
Who may be able to join
- gastro-enterologist or cardiologist with expertise in treating SBS patients resulting from AMI
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Antithrombotic Management of Acute Mesenteric Ischaemia: Case-based Survey
Guidelines on the acute and long-term pharmacological treatment of acute mesenteric ischaemia (AMI) recommend the use of thrombolytic, antiplatelet or anticoagulant therapy depending on the aetiology of AMI and the use of stenting but only few details are given on the choice of the drug, dose and duration of treatment. Besides, recommendations are mainly based on data on coronary, cerebral and other peripheral artery diseases and do also not take into account the altered drug absorption in patients with short bowel syndrome, in which AMI can result.This case-based survey will inform us on the current international clinical practice of long-term antithrombotic management of AMI.
- Conditions
- Acute Mesenteric Ischemia, Short Bowel Syndrome
- Being tested
- Survey
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Online survey questioning the current clinical practice on long-term antithrombotic management of AMI in SBS patients
| Study group | Role | What they receive |
|---|---|---|
| Gastro-enterologists and anticoagulation specialists | An online survey will be sent to question current clinical practice in long-term antithrombotic management of AMI in SBS patients. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of antithrombotic therapy
Overview of the type of long-term antithrombotic therapy that is prescribed in SBS patients with AMI, depending on the anatomy of the gastrointestinal tract, the aetiology of AMI and whether or not revascularisation of the occluding blood vessel has been performed
Measured: April 2023
Secondary outcomes (3)
Duration of antithrombotic therapy
Overview of the duration of long-term antithrombotic therapy in SBS patients with AMI depending on the anatomy of the gastrointestinal tract, the aetiology of AMI and whether or not revascularisation of the occluding blood vessel has been performed.
Measured: April 2023
Initial dose of antithrombotic therapy
Overview of the initial dose of long-term antithrombotic therapy in SBS patients with AMI depending on the anatomy of the gastrointestinal tract, the aetiology of AMI and whether or not revascularisation of the occluding blood vessel has been performed.
Measured: April 2023
Dose adjustments of antithrombotic therapy
Overview of any dose adjustments of long-term antithrombotic therapy in SBS patients with AMI depending on the anatomy of the gastrointestinal tract, the aetiology of AMI and whether or not revascularisation of the occluding blood vessel has been performed.
Measured: April 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start30 Jun 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706012
- Sponsor's protocol ID
- s67503
- Status last verified
- Nov 2023
- First submitted
- 20 Jan 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Antithrombotic Management of Acute Mesenteric Ischaemia: Case-based Survey
- ClinicalTrials.gov ID
- NCT05706012
- Acronym / sponsor ID
- s67503
- Conditions
- Acute Mesenteric Ischemia, Short Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 31 Jan 2023 (actual)
- 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.
Guidelines on the acute and long-term pharmacological treatment of acute mesenteric ischaemia (AMI) recommend the use of thrombolytic, antiplatelet or anticoagulant therapy depending on the aetiology of AMI and the use of stenting but only few details are given on the choice of the drug, dose and duration of treatment. Besides, recommendations are mainly based on data on coronary, cerebral and other peripheral artery diseases and do also not take into account the altered drug absorption in patients with short bowel syndrome, in which AMI can result.This case-based survey will inform us on the current international clinical practice of long-term antithrombotic management of AMI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastro-enterologists and anticoagulation specialists | – | Other: SurveyAn online survey will be sent to question current clinical practice in long-term antithrombotic management of AMI in SBS patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- international gastro-enterologists an cardiologists
Key inclusion criteria (1 listed)
- gastro-enterologist or cardiologist with expertise in treating SBS patients resulting from AMI
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| SurveyOnline survey questioning the current clinical practice on long-term antithrombotic management of AMI in SBS patients | Other | Gastro-enterologists and anticoagulation specialists |
Primary outcome
Type of antithrombotic therapy
Time frame: April 2023
Overview of the type of long-term antithrombotic therapy that is prescribed in SBS patients with AMI, depending on the anatomy of the gastrointestinal tract, the aetiology of AMI and whether or not revascularisation of the occluding blood vessel has been performed
3 secondary outcomes
Duration of antithrombotic therapy
Time frame: April 2023
Initial dose of antithrombotic therapy
Time frame: April 2023
Dose adjustments of antithrombotic therapy
Time frame: April 2023
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 9 May 2024.
- Individual participant dataSharing planned: No. no IPD will be shared with other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Mesenteric Ischemia and Short Bowel Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 9 May 2024. 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 Belgium. 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.
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?
Type of antithrombotic therapy (time frame: April 2023). 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 9 May 2024.