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Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage

This study is not yet open for participant recruitment.
Verified January 2013 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01779713
First received: January 10, 2013
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

Rational: The main danger with intracranial aneurism is its rupture conjugated with subarachnoid hemorrhage (SAH) occurrence. SAH is a severe pathology leading not only to neurological but also extra cerebral disorders. The major cause of morbidity and mortality when developing a SAH is the secondary development of a delayed cerebral ischemia consecutive to a prolonged vasospasm of cerebral arteries. The understanding of the pathophysiological mechanisms of SAH complication, such as vasospasm which is the more frequent, is essential.

Vasospasm is defined as a reversible shrinking of an artery lumen diameter in the subarachnoid space, beginning generally between 4 and 12 days after the hemorrhage. Such a vasospasm could have a huge clinical impact leading to delayed neurological ischemic deficiency in 17 to 40 % of cases. Up to day, mechanisms involved in vasospasm occurrence are not well described.

Disposing of well-established genetics and transcriptomics databases along with cerebral ischemia and inflammation is essential to unravel the mechanisms leading to vasospasm occurrence on SAH patients. It will enable researchers to better comprehend SAH pathology and elaborate an efficient and individualized therapeutic strategy to SAH acute phase in order to reduce the risk of vasospasm occurrence.

Aims: 1) Constitute DNA and RNA Biobank via blood proofing oh SAH patients 2) Constitute a database grouping clinical and biological data 3) Look for genetic and transcriptomic early markers via genomic approaches 4) Correlate these different markers with vasospasm occurrence and clinical evolution of the patients

Study: Patients inclusion will be done following their admission (D1) in the " unité de réanimation neurochirurgicale" of Pitié-Salpètrière Hospital. After obtaining of the informed consent, blood proofing will be realized daily during 12 days: one daily 2.5ml tube for the transcriptomic study and a single 10ml EDTA tube for genetic analyses. Clinical and biological follow-up will be performed as usual.

200 patients will be initially included during 2 to 3 years for the transcriptomic study of which 1/3 will develop vasospastic complication. The transcriptomic study will thus be performed by comparing patients developing or not developing this complication

Expected Results: Unravel vasospasm early genetic markers.


Condition Intervention
Aneurysmal Subarachnoid Hemorrhage
Vasospasm
 Genetic: Case-control transcriptomic study

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Discovery of the Risk Factors Associated to the Development of Vasospasm Following a Sub-arachnoid Aneurismal Hemorrhage Via Genomic Studies Including Genetic and Transcriptomic

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Evidence of clinically definite vasospasm [ Time Frame: Between intensive care unit admission and day twelve ] [ Designated as safety issue: No ]

    Any cases will be reviewed by an expert committee to establish vasospasm diagnosis

    Diagnosis criteria:

    • Cerebral angiography,
    • Trans-cranial Doppler of the MCA at 120 cm/s or two days of changing in the mean speed of the MCA at trans-cranial Doppler superior to 50 cm/s.
    • Development of new clinical symptoms for conscious patients


Secondary Outcome Measures:
  • Rankin Score [ Time Frame: 6 months and 1 year after ICU discharge ] [ Designated as safety issue: No ]
  • Glasgow outcome score (GOS) [ Time Frame: 6 months and 1 year after ICU discharge ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Vasospastic patients
Any patient send to the neuro-anesthesia intensive care unit in the 48 hours following an aneurismal sub-arachnoid hemorrhage and treated in the 96 first hours (embolization or surgery) and developing a vasospasm during the first 12 days after the bleeding; aged more than 18; of Caucasian origin; affiliated to a social care service; having (or one of is related if he is comatose) given its informed consent
 Genetic: Case-control transcriptomic study
No intervention
Control patients
Any patient send to the neuro-anesthesia intensive care unit in the 48 hours following an aneurismal sub-arachnoid hemorrhage and treated in the 96 first hours (embolization or surgery) not developing a vasospasm during the first 12 days after the bleeding; aged more than 18; of Caucasian origin; affiliated to a social care service; having (or one of is related if he is comatose) given its informed consent
 Genetic: Case-control transcriptomic study
No intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Caucasian subjects, aged more than 18, suffering of sub-arachnoid hemorrhage

Criteria

Inclusion Criteria:

  • Patient entering the neurosurgical unit in the 48 hours following an aneurismal sub-arachnoid hemorrhage and treated in the 96 first hours (embolization or surgery)
  • Aged more than 18
  • Caucasian origin
  • Affiliated to a social care service
  • Having (or one of is related if he is comatose) given its informed consent

Exclusion Criteria:

  • Subjects which do not have a social care protection
  • Subjects (or one of is related if he is comatose) refusing to sign the consent
  • Subjects being under a protective juridical system for adults
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779713

Contacts
Contact: Vincent Degos, MD PhD 01 42 16 16 79 ext +33 degosv@gmail.com
Contact: Paola Sanchez, MD PhD 01 42 16 16 79 ext +33 paola.sanchez@psl.aphp.fr

Locations
France
Neuro-anesthesia intensive care unit, Pitié-Salpétrière hospital Not yet recruiting
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Sophie Garnier, Lecturer INSERM and University Pierre and Marie Curie
Study Chair: Louis Puybasset, MD PhD Pierre and Marie Curie University
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01779713     History of Changes
Other Study ID Numbers: C10-15, 2012-A00935-38
Study First Received: January 10, 2013
Last Updated: January 28, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Aneurysmal subarachnoid hemorrhage
Vasospasm
Transcriptomic
Case-Control Study

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013