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Searching Biomarkers of Acute Intestinal Ischemic Injuries (Survibio)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518099
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Acute Mesenteric Ischemia Biological: blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 163 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Searching Biomarkers of Acute Intestinal Ischemic Injuries
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : May 22, 2020
Estimated Study Completion Date : May 22, 2021

Arm Intervention/treatment
Experimental: Patient
Any patient admitted for acute abdomen condition with or without ischemic causes.
Biological: blood 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
Other Name: urine sampling

Experimental: witness Biological: blood 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
Other Name: urine sampling




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. mortality and causes [ Time Frame: 2 years ]
  2. Intestinal resection ratio [ Time Frame: 2 years ]
  3. acute intestinal ischemic injury relapse ratio [ Time Frame: 2 years ]
  4. short gut syndrome features [ Time Frame: 2 years ]
  5. persistency of mesenteric ischemia clinical signs or of ischemic gastric stenosis [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

• lack of abdominal CT scan


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518099


Locations
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France
Corcos Olivier Recruiting
Clichy, France
Contact: Olivier Corcos    0140875695    olivier.corcos@aphp.fr   
Contact: Katell Peoc'h    0140875368      
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03518099    
Other Study ID Numbers: 2017-A02211-52
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mesenteric Ischemia
Ischemia
Pathologic Processes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peritoneal Diseases
Vascular Diseases
Cardiovascular Diseases