Intestinal ManipulationIMMONCT02189512
Study on the Effect of Surgical Intestinal Manipulation
A study testing blood sampling in people with Intestinal Manipulation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to study the impact of brain death and surgical small bowel manipulation on the release of different types of monocytes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Manipulation
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- May 2014to Jun 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are brain death
- patients who undergo an elective abdominal aortic aneurysm repair
Who cannot join
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: CD14/CD16 Activation in Brain-death Organ Donors and Effect of Surgical Intestinal Manipulation
The aim of this study is to study the impact of brain death and surgical small bowel manipulation on the release of different types of monocytes.
- Conditions
- Intestinal Manipulation
- Being tested
- blood sampling
- Keywords
- brain-death organ donors, intestinal manipulation, monocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
cases - blood sampling controles - blood sampling
| Study group | Role | What they receive |
|---|---|---|
| brain death organ donors | Other | cases - blood sampling Receives: Other: blood sampling |
| abdominal aortic aneurysm repair | Other | controls - blood sampling Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
subtypes of monocytes
evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection
Measured: 1 day
evaluate effect of intestinal manipulation
evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal ManipulationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Pirenne, MD,PhD, Principal investigator, Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189512
- Sponsor's protocol ID
- IMMO-20140206
- Acronym
- IMMO
- Status last verified
- May 2014
- First submitted
- 27 May 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD14/CD16 Activation in Brain-death Organ Donors and Effect of Surgical Intestinal Manipulation
- ClinicalTrials.gov ID
- NCT02189512
- Acronym / sponsor ID
- IMMO / IMMO-20140206
- Conditions
- Intestinal Manipulation
- Keywords
- brain-death organ donors, intestinal manipulation, monocytes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 14 Jul 2014 (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 aim of this study is to study the impact of brain death and surgical small bowel manipulation on the release of different types of monocytes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brain death organ donors | Other | Other: blood samplingcases - blood sampling |
| abdominal aortic aneurysm repair | Other | Other: blood samplingcontrols - blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who are brain death
- patients who undergo an elective abdominal aortic aneurysm repair
Key exclusion criteria (1 listed)
- < 18 years of age
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 |
|---|---|---|
| blood samplingcases - blood sampling controles - blood sampling | Other | abdominal aortic aneurysm repair, brain death organ donors |
Primary outcome
subtypes of monocytes
Time frame: 1 day
evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection
evaluate effect of intestinal manipulation
Time frame: 1 day
evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
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.
Jacques Pirenne, MD,PhD principal investigator
Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Intestinal Manipulation, 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 2 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: status not confirmed, as of the sponsor's last update on 14 Jul 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurens Ceulemans, MD (+32 16 341545, Ceulemans.laurens@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subtypes of monocytes (time frame: 1 day). The study lists 2 primary outcomes in all. 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 14 Jul 2014; AzTrials last refreshed its copy on 3 Nov 2026.