Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779713
• Other study ID #: C10-15
• Secondary ID: 2012-A00935-38
• Status: Completed
• Start date: February 4, 2013
• Est. completion date: July 4, 2016

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 4, 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm

Intervention

Genetic:
• Case-control transcriptomic study
No intervention

Locations

Country	Name	City	State
France	Neuro-anesthesia intensive care unit, Pitié-Salpétrière hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically definite vasospasm	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	Between intensive care unit admission and day twelve
Secondary	Rankin Score		6 months and 1 year after ICU discharge
Secondary	Glasgow outcome score (GOS)		6 months and 1 year after ICU discharge