Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage

NCT ID: NCT01779713

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 89 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-04
• Study Completion Date: 2016-08-15

Brief 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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Vasospasm

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Case-control transcriptomic study

Intervention Type: GENETIC

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

Case-control transcriptomic study

Intervention Type: GENETIC

No intervention

Interventions

Case-control transcriptomic study

No intervention

Intervention Type: GENETIC

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Garnier, Lecturer

Role: STUDY_DIRECTOR

INSERM and University Pierre and Marie Curie

Louis Puybasset, MD PhD

Role: STUDY_CHAIR

Pierre and Marie Curie University

Locations

Neuro-anesthesia intensive care unit, Pitié-Salpétrière hospital

Paris, , France

Countries

France

References

Pulcrano-Nicolas AS, Proust C, Clarencon F, Jacquens A, Perret C, Roux M, Shotar E, Thibord F, Puybasset L, Garnier S, Degos V, Tregouet DA. Whole-Blood miRNA Sequencing Profiling for Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage. Stroke. 2018 Sep;49(9):2220-2223. doi: 10.1161/STROKEAHA.118.021101.

Reference Type: RESULT

PMID: 30354977 (View on PubMed)

Pulcrano-Nicolas AS, Jacquens A, Proust C, Clarencon F, Perret C, Shotar E, Puybasset L, Le Goff W, Degos V, Tregouet DA, Garnier S. Whole blood levels of S1PR4 mRNA associated with cerebral vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2019 Nov 29;133(6):1837-1841. doi: 10.3171/2019.9.JNS191305. Print 2020 Dec 1.

Reference Type: RESULT

PMID: 31783362 (View on PubMed)

Other Identifiers

2012-A00935-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

C10-15

Identifier Type: -

Identifier Source: org_study_id