Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

January 10, 2013
January 28, 2013
January 2013
July 2017   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01779713 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage
Discovery of the Risk Factors Associated to the Development of Vasospasm Following a Sub-arachnoid Aneurismal Hemorrhage Via Genomic Studies Including Genetic and Transcriptomic

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Non-Probability Sample

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

  • Aneurysmal Subarachnoid Hemorrhage
  • Vasospasm
Genetic: Case-control transcriptomic study
No intervention
  • 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
    Intervention: Genetic: Case-control transcriptomic study
  • 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
    Intervention: Genetic: Case-control transcriptomic study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
December 2017
July 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
France
 
NCT01779713
C10-15, 2012-A00935-38
No
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Not Provided
Study Director: Sophie Garnier, Lecturer INSERM and University Pierre and Marie Curie
Study Chair: Louis Puybasset, MD PhD Pierre and Marie Curie University
Institut National de la Santé Et de la Recherche Médicale, France
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP