Aneuvrysmal Subarachnoid HemorrhageAPICRASHNCT06375889
Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage
An observational study of Aneuvrysmal Subarachnoid Hemorrhage and Delayed Cerebral Ischemia, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Aneurysmal subarachnoid haemorrhage is a complex pathology, the pathophysiology of which is still imperfectly understood. Its morbidity and mortality remain significant. In addition to the damage sustained by the brain in the immediate aftermath of aneurysmal rupture, which is inaccessible to life-saving treatment, a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneuvrysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Endotheliopathy
- What is being tested?
- blood test
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jun 2024to 24 Jan 2026
- 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: We therefore chose to carry out an exhaustive recruitment of the active file of consecutive patients eligible for the study selection criteria. In the Medical ICA and Neurovascular ICU Department of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon, treating patients with sub-aneurysmal meningeal haemorrhage or intraparenchymal haemorrhage. 40 patients in each group
Who may be able to join
- Male and Female Adults ≤18 years of age.
- Hospitalised in the neurological intensive care unit of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon following an aneurysmal meningeal haemorrhage of any modified Fischer score, previously diagnosed by cerebral CT scan.
- Patients admitted to the neurological intensive care unit or the NICU of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon for an intra-parenchymal haematoma.
- Patient who has been informed and has formulated his/her non-opposition, or close relative of the patient who has been informed and has formulated his/her non-opposition.
- Affiliated to a social security scheme.
Who cannot join
- Non-aneurysmal SAH
- Ischaemic stroke
- Patients with previously known platelet function disorders
- Pregnant or breast-feeding women
- Patients under legal protection (guardianship, curatorship, safeguard of justice)
- Patients under compulsory psychiatric care
- Patients taking part in a study which may interfere with the present study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital
Bron, Auvergne-Rhône-Alpes, 69005
Neurovascular intensive care unit department, Pierre Wertheimer hospital
Bron, Auvergnes-Rhones-Alpes, 69005
About this study
Aneurysmal subarachnoid haemorrhage is a complex pathology, the pathophysiology of which is still imperfectly understood. Its morbidity and mortality remain significant. In addition to the damage sustained by the brain in the immediate aftermath of aneurysmal rupture, which is inaccessible to life-saving treatment, a significant proportion of lesions occur at a distance from the initial event. Delayed cerebral ischaemia is one of the most morbid complications. It combines an inflammatory pattern with vascular dysfunction and neuronal excitotoxicity, leading to avoidable secondary neuronal loss.
Vascular dysfunction is mediated by a loss of homeostasis between endothelial cells and figurative blood cells, including platelets. However, the interrelationship between these elements and the precise chronology of the dysfunction remain imperfectly described to date.
It therefore seems appropriate to propose temporal monitoring of platelet activation kinetics over time, combined with concomitant collection of markers of endothelial damage, in order to clarify the vascular chronobiology of this pathology.
- Conditions
- Aneuvrysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Endotheliopathy, Platelets Kinetic
- Being tested
- blood test
- Keywords
- aSHA, DCI, Endotheliopathy, Platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testOther
During the routine blood test of the patient, 5 more tubes of 2.7 milliliters (mL) will be collected to make Platelet Activation Analysis
| Study group | Role | What they receive |
|---|---|---|
| aSAH group | Patient hospitalised following the occurrence of an aneurysmal subarachnoid haemorrhage of any grade of severity. Receives: Other: blood test | |
| IPH group | Patient hospitalised following the occurrence of a non-traumatic intra-parenchymal haematoma. Receives: Other: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation.
To describe the temporal kinetics of the percentage of activated platelets over time between patients with aHSA compared with the control group, consisting of patients with spontaneous intraparenchymal haematomas. Platelet cell activation is defined by the concomitant presence of the following markers: P-Selectin (CD-62); Gp Integrin Alpha IIb Beta 3 (CD-41); phosphatidylserine.
A mixed effects linear regression model will be used for data analysis.
Measured: Day of blood sample (inclusion visit) Day 3, day 5, day 7 and day 10 after inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start14 Jun 2024
- Primary completion24 Jan 2026
- Study completion24 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneuvrysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Chardon, MD;Msc, Principal investigator, Intensive care department; Pierre Wertheimer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375889
- Sponsor's protocol ID
- 69HCL24_0250
- Other IDs
- 2024-A00796-41
- Acronym
- APICRASH
- Status last verified
- Jan 2026
- First submitted
- 16 Apr 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06375889
- Acronym / sponsor ID
- APICRASH / 69HCL24_0250
- Conditions
- Aneuvrysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Endotheliopathy, Platelets Kinetic
- Keywords
- aSHA, DCI, Endotheliopathy, Platelets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 24 Jan 2026 (actual)
- Study completion
- 24 Jan 2026 (actual)
- First posted
- 19 Apr 2024 (actual)
- 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.
Aneurysmal subarachnoid haemorrhage is a complex pathology, the pathophysiology of which is still imperfectly understood. Its morbidity and mortality remain significant. In addition to the damage sustained by the brain in the immediate aftermath of aneurysmal rupture, which is inaccessible to life-saving treatment, a significant proportion of lesions occur at a distance from the initial event. Delayed cerebral ischaemia is one of the most morbid complications. It combines an inflammatory pattern with vascular dysfunction and neuronal excitotoxicity, leading to avoidable secondary neuronal loss.
Vascular dysfunction is mediated by a loss of homeostasis between endothelial cells and figurative blood cells, including platelets. However, the interrelationship between these elements and the precise chronology of the dysfunction remain imperfectly described to date.
It therefore seems appropriate to propose temporal monitoring of platelet activation kinetics over time, combined with concomitant collection of markers of endothelial damage, in order to clarify the vascular chronobiology of this pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aSAH group | – | Other: blood testPatient hospitalised following the occurrence of an aneurysmal subarachnoid haemorrhage of any grade of severity. |
| IPH group | – | Other: blood testPatient hospitalised following the occurrence of a non-traumatic intra-parenchymal haematoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We therefore chose to carry out an exhaustive recruitment of the active file of consecutive patients eligible for the study selection criteria. In the Medical ICA and Neurovascular ICU Department of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon, treating patients with sub-aneurysmal meningeal haemorrhage or intraparenchymal haemorrhage. 40 patients in each group
Key inclusion criteria (5 listed)
- Male and Female Adults ≤18 years of age.
- Hospitalised in the neurological intensive care unit of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon following an aneurysmal meningeal haemorrhage of any modified Fischer score, previously diagnosed by cerebral CT scan.
- Patients admitted to the neurological intensive care unit or the NICU of the Pierre Wertheimer Hospital of the Hospices Civils de Lyon for an intra-parenchymal haematoma.
- Patient who has been informed and has formulated his/her non-opposition, or close relative of the patient who has been informed and has formulated his/her non-opposition.
- Affiliated to a social security scheme.
Key exclusion criteria (7 listed)
- Non-aneurysmal SAH
- Ischaemic stroke
- Patients with previously known platelet function disorders
- Pregnant or breast-feeding women
- Patients under legal protection (guardianship, curatorship, safeguard of justice)
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 |
|---|---|---|
| blood testDuring the routine blood test of the patient, 5 more tubes of 2.7 milliliters (mL) will be collected to make Platelet Activation Analysis | Other | IPH group, aSAH group |
Primary outcome
The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation.
Time frame: Day of blood sample (inclusion visit) Day 3, day 5, day 7 and day 10 after inclusion visit
To describe the temporal kinetics of the percentage of activated platelets over time between patients with aHSA compared with the control group, consisting of patients with spontaneous intraparenchymal haematomas. Platelet cell activation is defined by the concomitant presence of the following markers: P-Selectin (CD-62); Gp Integrin Alpha IIb Beta 3 (CD-41); phosphatidylserine. A mixed effects linear regression model will be used for data analysis.
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 27 Jan 2026.
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.
Nicolas Chardon, MD;Msc principal investigator
Intensive care department; Pierre Wertheimer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneuvrysmal Subarachnoid Hemorrhage and Delayed Cerebral Ischemia, run by Hospices Civils de Lyon at 2 sites 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 7 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation. (time frame: Day of blood sample (inclusion visit) Day 3, day 5, day 7 and day 10 after inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.