NCT01779713

Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage

Completed Last updated 18 November 2025

What this trial tests

trial testing Case-control transcriptomic study in Aneurysmal Subarachnoid Hemorrhage in 89 participants. Completed in 15 August 2016.

Timeline

4 February 2013

Primary endpoint
15 August 2016

15 August 2016

Quick facts

Lead sponsor	Institut National de la Santé Et de la Recherche Médicale, France
Status	Completed
Study type	OBSERVATIONAL
Enrollment	89
Start date	4 February 2013
Primary completion	15 August 2016
Estimated completion	15 August 2016
Sites	1 location across France

Drugs / interventions tested

• Case-control transcriptomic study

Conditions studied

• Aneurysmal Subarachnoid Hemorrhage — all drugs for Aneurysmal Subarachnoid Hemorrhage →
• Vasospasm — all drugs for Vasospasm →

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France — full company profile →

Who can join

18 and older, any sex, with Aneurysmal Subarachnoid Hemorrhage or Vasospasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biomarker Application for Precision Medicine in Stroke.
   Simpkins AN, Janowski M, Oz HS, Roberts J, et al · · 2020 · cited 70× · PMID 31848851 · DOI 10.1007/s12975-019-00762-3
2. Whole-Blood miRNA Sequencing Profiling for Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage.
   Pulcrano-Nicolas AS, Proust C, Clarençon F, Jacquens A, et al · · 2018 · cited 21× · PMID 30354977 · DOI 10.1161/strokeaha.118.021101
3. Molecular heterogeneity in human stroke - What can we learn from the peripheral blood transcriptome?
   Stamova B, Knepp B, Rodriguez F. · · 2026 · cited 4× · PMID 40079561 · DOI 10.1177/0271678x251322598