Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage

NCT01779713 | Completed

• 2 other identifiers: C10-152012-A00935-38
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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

Keywords

Aneurysmal subarachnoid hemorrhage; Vasospasm; Transcriptomic; Case-Control Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rankin Score

  6 months and 1 year after ICU discharge

• Glasgow outcome score (GOS)

  6 months and 1 year after ICU discharge

Study Arms (2)

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

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

Genetic: Case-control transcriptomic study

Interventions

Case-control transcriptomic study GENETIC

No intervention

Control patients; Vasospastic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Neuro-anesthesia intensive care unit, Pitié-Salpétrière hospital

Paris, 75013, France

Location

Related Publications (2)

• 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.

  PMID: 30354977 RESULT

• 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.

  PMID: 31783362 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie Garnier, Lecturer

  INSERM and University Pierre and Marie Curie

  STUDY DIRECTOR

• Louis Puybasset, MD PhD

  Pierre and Marie Curie University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 30, 2013
• Study Start: February 4, 2013
• Primary Completion: August 15, 2016
• Study Completion: August 15, 2016
• Last Updated: November 18, 2025

Record last verified: 2022-02

Locations

FR (1)