Acute Mesenteric IschemiaSurvibioNCT03518099
Searching Biomarkers of Acute Intestinal Ischemic Injuries
A study testing blood sampling in people with Acute Mesenteric Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the SURVIBIO study is to characterize accurate biomarkers for acute mesenteric ischemia, in particular at early stages. In the study, the development of biomarkers will be based on the analysis of human biological samples from patients and controls that will be conserved in a biological library. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Mesenteric Ischemia
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2018to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- age> 18 years
- Acute abdominal pain requiring an injected abdominal injected CT scan, at best at non-injected / early arterial / portal time
- Admitted or attended in Beaujon and / or Bichat hospitals
- Patient covered by a social security scheme
- Written consent
Who cannot join
- lack of abdominal CT scan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandre Nuzzo contact
France1 site, 1 recruiting
- Recruiting
Corcos Olivier
Clichy
Olivier Corcos, 0140875695, olivier.corcos@aphp.fr
Katell Peoc'h, 0140875368
About this study
The aim of the SURVIBIO study is to characterize accurate biomarkers for acute mesenteric ischemia, in particular at early stages.
In the study, the development of biomarkers will be based on the analysis of human biological samples from patients and controls that will be conserved in a biological library. Samples will be analysed in the Laboratory for Vascular Translational Sciences (LVTS, Inserm U1148), in the Department of Biochemistry (Pr Puy, Dr Peoc'h), in Paris V university , in Imperial College of London (Pr Dumas), in Jacques Monod Institute and in Maastricht University Medical Center . The candidate markers will be determined according to an a priori method (form markers already described in the literature) and with no a priori strategy using -omics methods.
Read the detailed description
Acute intestinal ischemic injury (i3), or intestinal infarction, is an extremely severe condition that affects the intestine, with a mortality rate that is over 80%, and with major anatomical and functional consequences for the surviving patients, mainly because of intestinal resections, which are responsible for chronic intestinal failure, long term parenteral nutrition and an important financial impact on public health.
Even though the incidence of i3 is largely underestimated (mainly because of the lack of knowledge of diagnostic), more than 1000 patients have been surveyed in Paris's hospital through Information Systems Medicalization Program (K550) searching in 2014. Furthermore, i3 represents a digestive emergency for which the only known prognostic factors are the precocity of the diagnostic and treatment.
Investigators have opened in January 2016 the first structure for intestinal vascular emergency (SURVI) within the Groups University Hospitals Paris-Nord Val de Seine. This unique and innovative intensive care structure, which is dedicated to the multidisciplinary treatment of acute mesenteric ischemia, doesn't have any equivalent, and allows the constitution of cohorts with biological and tissular bio-banking.
SURVI provides the patients suffering from intestinal ischemia a "gut and life staving strategy", through a multimodal and multidisciplinary management (M3). M3 is based on a simple algorithm and it brings together experts in intestinal and vascular pathologies that come from different medical disciplines, such as gastroenterology, interventional radiology, vascular surgery, digestive surgery, anaesthesiology and cardiology.
Therefore, the therapeutic strategies aim to limit the complications, to protect the viable intestine, and to remove the necrotic intestine.
Beside the therapeutic strategy that is proposed by SURVI, improvement of the clinical treatment needs to be associated with the finding of new diagnostic tools of intestinal ischemia, that will have to be early, sensitive and specific, as it is the case for troponin in the context of myocardium ischemia.
So far, no biomarker that is sensible and specific enough for the early diagnostic of intestinal ischemia has been found. The CT-scan which is the only diagnostic tool that allow investigators to confirm the diagnostic, in theory, presents a lack of sensibility for the early, not complicated and non-occlusive forms of the disease.
The main prognostic factor of acute intestinal ischemia is the precocity of diagnostic and treatment. Indeed, the mortality rate sharply increases with the occurrence of intestinal necrosis. The problem is that the phases of the disease that precede intestinal necrosis are extremely difficult to diagnose without any biomarker that is sensible and specific enough. Therefore, it is of major importance for the clinician to be provided with one or more biomarker that will help to validate or invalidate the diagnostic of intestinal ischemia, in the context of any acute abdomen condition.
The aim of the SURVIBIO study is therefore to characterize biomarkers for early diagnostic of acute mesenteric ischemia.
In the prospective part of the study, the development of biomarkers will be based on analysis of human biological samples from patients and controls that will be conserved in a biological library and that will be analysed in the Laboratory for Vascular Translational Sciences (LVTS, Inserm U1148) and in the Department of Biochemistry (Pr Puy, Dr Peoc'h). Among the candidate markers, investigators will analyse I-FABP (molecule associated with enterocyte damage at the top of the intestinal villi), D-Lactate (which is specific of intestinal E.coli, and which indicates bacterial translocation, when found in the blood), Citrulline (which is a marker of the functional profile of enterocytes) and ischemia-modified albumin.
In addition to this approach to "candidate" markers based on very brief data from the literature, investigators also wish to develop an unconventional approach, combining a medical approach of proteomics, combining tandem spectrometry with MALDI and establishment of cytokine profile via a multi-complex approach to the emergence of new potential diagnostic biomarkers. The profiles obtained for patients with ischemia are available at profiles obtained on "control" patients, unaffected.
- Conditions
- Acute Mesenteric Ischemia
- Being tested
- blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
Also called urine sampling
Two tubes of 5ml of blood will be collected for Serum collection, 3 tubes of 5 ml of blood taken for plasma collection and 2 tubes of 7 ml of blood taken for DNA collection
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Any patient admitted for acute abdomen condition with or without ischemic causes. Receives: Biological: blood sampling |
| witness | Experimental | Not described Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
observation of clinical-bio-scanographic pain related to a splanchnic-mesenteric, occlusive or non-occlusive vascular insufficiency, to abdominal CT angiography, in the absence of another identifiable cause
Measured: 2 years
Secondary outcomes (5)
mortality and causes
Measured: 2 years
Intestinal resection ratio
Measured: 2 years
acute intestinal ischemic injury relapse ratio
Measured: 2 years
short gut syndrome features
Measured: 2 years
persistency of mesenteric ischemia clinical signs or of ischemic gastric stenosis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start16 Nov 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
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 Assistance Publique - Hôpitaux de ParisThe 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
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518099
- Sponsor's protocol ID
- 2017-A02211-52
- Acronym
- Survibio
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2018
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching Biomarkers of Acute Intestinal Ischemic Injuries
- ClinicalTrials.gov ID
- NCT03518099
- Acronym / sponsor ID
- Survibio / 2017-A02211-52
- Conditions
- Acute Mesenteric Ischemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 8 May 2018 (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.
The aim of the SURVIBIO study is to characterize accurate biomarkers for acute mesenteric ischemia, in particular at early stages.
In the study, the development of biomarkers will be based on the analysis of human biological samples from patients and controls that will be conserved in a biological library. Samples will be analysed in the Laboratory for Vascular Translational Sciences (LVTS, Inserm U1148), in the Department of Biochemistry (Pr Puy, Dr Peoc'h), in Paris V university , in Imperial College of London (Pr Dumas), in Jacques Monod Institute and in Maastricht University Medical Center . The candidate markers will be determined according to an a priori method (form markers already described in the literature) and with no a priori strategy using -omics methods.
Detailed description
Acute intestinal ischemic injury (i3), or intestinal infarction, is an extremely severe condition that affects the intestine, with a mortality rate that is over 80%, and with major anatomical and functional consequences for the surviving patients, mainly because of intestinal resections, which are responsible for chronic intestinal failure, long term parenteral nutrition and an important financial impact on public health.
Even though the incidence of i3 is largely underestimated (mainly because of the lack of knowledge of diagnostic), more than 1000 patients have been surveyed in Paris's hospital through Information Systems Medicalization Program (K550) searching in 2014. Furthermore, i3 represents a digestive emergency for which the only known prognostic factors are the precocity of the diagnostic and treatment.
Investigators have opened in January 2016 the first structure for intestinal vascular emergency (SURVI) within the Groups University Hospitals Paris-Nord Val de Seine. This unique and innovative intensive care structure, which is dedicated to the multidisciplinary treatment of acute mesenteric ischemia, doesn't have any equivalent, and allows the constitution of cohorts with biological and tissular bio-banking.
SURVI provides the patients suffering from intestinal ischemia a "gut and life staving strategy", through a multimodal and multidisciplinary management (M3). M3 is based on a simple algorithm and it brings together experts in intestinal and vascular pathologies that come from different medical disciplines, such as gastroenterology, interventional radiology, vascular surgery, digestive surgery, anaesthesiology and cardiology.
Therefore, the therapeutic strategies aim to limit the complications, to protect the viable intestine, and to remove the necrotic intestine.
Beside the therapeutic strategy that is proposed by SURVI, improvement of the clinical treatment needs to be associated with the finding of new diagnostic tools of intestinal ischemia, that will have to be early, sensitive and specific, as it is the case for troponin in the context of myocardium ischemia.
So far, no biomarker that is sensible and specific enough for the early diagnostic of intestinal ischemia has been found. The CT-scan which is the only diagnostic tool that allow investigators to confirm the diagnostic, in theory, presents a lack of sensibility for the early, not complicated and non-occlusive forms of the disease.
The main prognostic factor of acute intestinal ischemia is the precocity of diagnostic and treatment. Indeed, the mortality rate sharply increases with the occurrence of intestinal necrosis. The problem is that the phases of the disease that precede intestinal necrosis are extremely difficult to diagnose without any biomarker that is sensible and specific enough. Therefore, it is of major importance for the clinician to be provided with one or more biomarker that will help to validate or invalidate the diagnostic of intestinal ischemia, in the context of any acute abdomen condition.
The aim of the SURVIBIO study is therefore to characterize biomarkers for early diagnostic of acute mesenteric ischemia.
In the prospective part of the study, the development of biomarkers will be based on analysis of human biological samples from patients and controls that will be conserved in a biological library and that will be analysed in the Laboratory for Vascular Translational Sciences (LVTS, Inserm U1148) and in the Department of Biochemistry (Pr Puy, Dr Peoc'h). Among the candidate markers, investigators will analyse I-FABP (molecule associated with enterocyte damage at the top of the intestinal villi), D-Lactate (which is specific of intestinal E.coli, and which indicates bacterial translocation, when found in the blood), Citrulline (which is a marker of the functional profile of enterocytes) and ischemia-modified albumin.
In addition to this approach to "candidate" markers based on very brief data from the literature, investigators also wish to develop an unconventional approach, combining a medical approach of proteomics, combining tandem spectrometry with MALDI and establishment of cytokine profile via a multi-complex approach to the emergence of new potential diagnostic biomarkers. The profiles obtained for patients with ischemia are available at profiles obtained on "control" patients, unaffected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Biological: blood samplingAny patient admitted for acute abdomen condition with or without ischemic causes. |
| witness | Experimental | Biological: blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age> 18 years
- Acute abdominal pain requiring an injected abdominal injected CT scan, at best at non-injected / early arterial / portal time
- Admitted or attended in Beaujon and / or Bichat hospitals
- Patient covered by a social security scheme
- Written consent
Key exclusion criteria (1 listed)
- lack of abdominal CT scan
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 samplingAlso: urine samplingTwo tubes of 5ml of blood will be collected for Serum collection, 3 tubes of 5 ml of blood taken for plasma collection and 2 tubes of 7 ml of blood taken for DNA collection | Biological | Patient, witness |
Primary outcome
observation of clinical-bio-scanographic pain related to a splanchnic-mesenteric, occlusive or non-occlusive vascular insufficiency, to abdominal CT angiography, in the absence of another identifiable cause
Time frame: 2 years
5 secondary outcomes
mortality and causes
Time frame: 2 years
Intestinal resection ratio
Time frame: 2 years
acute intestinal ischemic injury relapse ratio
Time frame: 2 years
short gut syndrome features
Time frame: 2 years
persistency of mesenteric ischemia clinical signs or of ischemic gastric stenosis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Yes
Related trials for Acute Mesenteric Ischemia
Recruiting
Evaluation of the Discriminative Abilities of Biomarkers for the Diagnosis of Acute Mesenteric Ischemia Compared With Another Similar Clinical Presentation: a Pilot Study
Acute Mesenteric Ischemia
Active, not recruiting
ThromBus Aspiration for Acute Mesenteric Artery Occlusion With Emergent Laparoscopic Surgery
Acute Mesenteric Ischemia
RecruitingObservational study
Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia
Non-Occlusive Mesenteric Ischaemia (NOMI), Acute Mesenteric Ischemia
RecruitingObservational study
Assessment of Quality of Life After Acute Mesenteric Ischemia
Acute Mesenteric Ischemia
Active, not recruitingObservational study
Incidence, Treatment and Outcome After Acute Mesenteric Ischemia in the Region of Västra Götaland, 2000-2023.
Mesenteric Artery Ischemia
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.
Alexandre Nuzzo contact
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 Acute Mesenteric Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact olivier corcos (140875000 ext. 33, olivier.corcos@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
observation of clinical-bio-scanographic pain related to a splanchnic-mesenteric, occlusive or non-occlusive vascular insufficiency, to abdominal CT angiography, in the absence of another identifiable cause (time frame: 2 years). 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 16 Dec 2025.