Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage
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|ClinicalTrials.gov Identifier: NCT01779713|
Recruitment Status : Unknown
Verified January 2013 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : January 30, 2013
Last Update Posted : April 27, 2015
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 or disease||Intervention/treatment|
|Aneurysmal Subarachnoid Hemorrhage Vasospasm||Genetic: Case-control transcriptomic study|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
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
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
- Evidence of clinically definite vasospasm [ Time Frame: Between intensive care unit admission and day twelve ]
Any cases will be reviewed by an expert committee to establish vasospasm diagnosis
- 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
- Rankin Score [ Time Frame: 6 months and 1 year after ICU discharge ]
- Glasgow outcome score (GOS) [ Time Frame: 6 months and 1 year after ICU discharge ]
Biospecimen Retention: Samples With DNA
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): NCT01779713
|Contact: Vincent Degos, MD PhD||01 42 16 16 79 ext +email@example.com|
|Contact: Paola Sanchez, MD PhD||01 42 16 16 79 ext +firstname.lastname@example.org|
|Neuro-anesthesia intensive care unit, Pitié-Salpétrière hospital||Recruiting|
|Paris, France, 75013|
|Study Director:||Sophie Garnier, Lecturer||INSERM and University Pierre and Marie Curie|
|Study Chair:||Louis Puybasset, MD PhD||Pierre and Marie Curie University|