Aneurysmal Subarachnoid HemorrhageNCT01779713
Transcriptomic Signature of Vasospasm Consecutive to Sub-arachnoid Aneurismal Hemorrhage
An observational study of Aneurysmal Subarachnoid Hemorrhage and Vasospasm, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Vasospasm
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2013to 15 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Caucasian subjects, aged more than 18, suffering of sub-arachnoid hemorrhage
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Neuro-anesthesia intensive care unit, Pitié-Salpétrière hospital
Paris, 75013
About this study
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
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.
Read more
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
- Being tested
- Case-control transcriptomic study
- Keywords
- Aneurysmal subarachnoid hemorrhage, Vasospasm, Transcriptomic, Case-Control Study
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case-control transcriptomic studyGenetic
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Genetic: Case-control transcriptomic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between intensive care unit admission and day twelve
Secondary outcomes (2)
Rankin Score
Measured: 6 months and 1 year after ICU discharge
Glasgow outcome score (GOS)
Measured: 6 months and 1 year after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study start4 Feb 2013
- Primary completion15 Aug 2016
- Study completion15 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sophie Garnier, Lecturer, Study director, INSERM and University Pierre and Marie CurieLouis Puybasset, MD PhD, Study chair, Pierre and Marie Curie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779713
- Sponsor's protocol ID
- C10-15
- Other IDs
- 2012-A00935-38
- Status last verified
- Feb 2022
- First submitted
- 10 Jan 2013
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30354977Pulcrano-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.
PubMed 31783362
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01779713
- Acronym / sponsor ID
- C10-15
- Conditions
- Aneurysmal Subarachnoid Hemorrhage, Vasospasm
- Keywords
- Aneurysmal subarachnoid hemorrhage, Vasospasm, Transcriptomic, Case-Control Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 4 Feb 2013 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vasospastic patients | – | Genetic: Case-control transcriptomic studyAny 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 |
| Control patients | – | Genetic: Case-control transcriptomic studyAny 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caucasian subjects, aged more than 18, suffering of sub-arachnoid hemorrhage
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case-control transcriptomic studyNo intervention | Genetic | Control patients, Vasospastic patients |
Primary outcome
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 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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 30354977Pulcrano-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.
- Results publication: PubMed 31783362Pulcrano-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Garnier, Lecturer study director
INSERM and University Pierre and Marie Curie
Louis Puybasset, MD PhD study chair
Pierre and Marie Curie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage and Vasospasm, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically definite vasospasm (time frame: Between intensive care unit admission and day twelve). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.