Subarachnoid HemorrhageSKinDCINCT04795362
S100B Kinetic During the Occurrence and Treatment of Delayed Cerebral Ischaemia After a Subarachnoid Haemorrhage.
An observational study of Subarachnoid Hemorrhage, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Nearly half of the survivors of subarachnoid haemorrhage (SAH) retain irreversible neurological damage resulting from the early lesions associated with the initial bleeding, and the occurrence of possible delayed cerebral ischaemia (DCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- blood sample
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Jul 2021to 17 Jun 2024
- 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: Adult patients hospitalized in neurological intensive care unit for subarachnoid hemorrhage, in whom the onset of delayed cerebral ischemia is suspected will be included.
Who may be able to join
- Adults
- Patient hospitalised in the neurological intensive care unit for a subarachnoid haemorrhage.
- Delayed cerebral ischaemia suspected during routine care.
- Presence of a catheter (arterial or venous) for repeated sampling.
- Patient having been informed and having formulated his non-opposition or close to the patient having been informed and having formulated his non-opposition. In this case, the patient's non-opposition will be collected as soon as his condition allows it.
Who cannot join
- Pregnant or breastfeeding women in class.
- Patients under legal protection, guardianship, curatorship, under judicial safeguard.
- Patients participating in a study that may interfere with this study.
- Persons under psychiatric care under duress
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Femme Mère Enfant
Bron, 69500
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
About this study
Nearly half of the survivors of subarachnoid haemorrhage (SAH) retain irreversible neurological damage resulting from the early lesions associated with the initial bleeding, and the occurrence of possible delayed cerebral ischaemia (DCI). The early diagnosis of the occurrence of an DCI is therefore a major challenge in order to optimise management before irreversible lesions are formed. However, the means of diagnosis are often not available, and up to a third of DCI are discovered on follow-up images when the lesions are already present. Among the markers of brain injury, S100 calcium-binding protein B (S100B) is an astrocyte protein released into the bloodstream at the time of the appearance of a brain lesion. Its short half-life makes it a prime candidate for patient follow-up to diagnose a new ischemic lesion and assess the effectiveness of its management.
Among the elements at the origin of DCI, the occurrence of proximal vasospasm is the main element on which we can have a therapeutic action. The strategy implemented in the department consists of performing a mechanical angioplasty when proximal vasospasm is detected with a decrease in downstream cerebral perfusion. Nevertheless the benefit of this therapeutic action is discussed and there is currently no early marker of the effectiveness of this procedure.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- blood sample
- Keywords
- subarachnoid haemorrhage, S100B, Delayed cerebral ischemia
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
5 tubes of 1 milliliters (ml) will be sampled on a catheter placed as part of the usual practice every hour for 4 hours (at Time 0, at Time 1 hour, at time 2hours, at Time 3 hours, at time 4 hours) as soon as DCI is suspected.
In the event of a mechanical angioplasty decision, the samples will be continued (Time 0, Time 2 hours, Time 4 hours, Time 6hours, Time 12 hours, Time 24 hours, so 6 samples of 1 ml).
| Study group | Role | What they receive |
|---|---|---|
| patients with Delayed cerebral ischemia | 50 adult patients hospitalized in neurological intensive care unit for subarachnoid hemorrhage, in whom the onset of delayed cerebral ischemia is suspected will be included. Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
S100B serum concentration after DCI suspicion.
S100B repeated samples, measure with an ELISA kit from ROCHE diagnostic.
Measurement of the evolution of the S100B during at T0, T1h, T2h, T3h, T4h after the suspicion of DCI by the physician in charge.
If an intravascular angioplasty procedure is performed S100B kinetic will be measured at T0, T2h, T4h, T6h, T12h and T24h after the procedure.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start20 Jul 2021
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795362
- Sponsor's protocol ID
- 69HCL20_1081
- Other IDs
- 2021-A00048-33
- Acronym
- SKinDCI
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2021
- Last updated
- 5 Feb 2025
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S100B Kinetic During the Occurrence and Treatment of Delayed Cerebral Ischaemia After a Subarachnoid Haemorrhage.
- ClinicalTrials.gov ID
- NCT04795362
- Acronym / sponsor ID
- SKinDCI / 69HCL20_1081
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid haemorrhage, S100B, Delayed cerebral ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 12 Mar 2021 (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.
Nearly half of the survivors of subarachnoid haemorrhage (SAH) retain irreversible neurological damage resulting from the early lesions associated with the initial bleeding, and the occurrence of possible delayed cerebral ischaemia (DCI). The early diagnosis of the occurrence of an DCI is therefore a major challenge in order to optimise management before irreversible lesions are formed. However, the means of diagnosis are often not available, and up to a third of DCI are discovered on follow-up images when the lesions are already present. Among the markers of brain injury, S100 calcium-binding protein B (S100B) is an astrocyte protein released into the bloodstream at the time of the appearance of a brain lesion. Its short half-life makes it a prime candidate for patient follow-up to diagnose a new ischemic lesion and assess the effectiveness of its management.
Among the elements at the origin of DCI, the occurrence of proximal vasospasm is the main element on which we can have a therapeutic action. The strategy implemented in the department consists of performing a mechanical angioplasty when proximal vasospasm is detected with a decrease in downstream cerebral perfusion. Nevertheless the benefit of this therapeutic action is discussed and there is currently no early marker of the effectiveness of this procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Delayed cerebral ischemia | – | Biological: blood sample50 adult patients hospitalized in neurological intensive care unit for subarachnoid hemorrhage, in whom the onset of delayed cerebral ischemia is suspected will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in neurological intensive care unit for subarachnoid hemorrhage, in whom the onset of delayed cerebral ischemia is suspected will be included.
Key inclusion criteria (5 listed)
- Adults
- Patient hospitalised in the neurological intensive care unit for a subarachnoid haemorrhage.
- Delayed cerebral ischaemia suspected during routine care.
- Presence of a catheter (arterial or venous) for repeated sampling.
- Patient having been informed and having formulated his non-opposition or close to the patient having been informed and having formulated his non-opposition. In this case, the patient's non-opposition will be collected as soon as his condition allows it.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women in class.
- Patients under legal protection, guardianship, curatorship, under judicial safeguard.
- Patients participating in a study that may interfere with this study.
- Persons under psychiatric care under duress
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 sample5 tubes of 1 milliliters (ml) will be sampled on a catheter placed as part of the usual practice every hour for 4 hours (at Time 0, at Time 1 hour, at time 2hours, at Time 3 hours, at time 4 hours) as soon as DCI is suspected. In the event of a mechanical angioplasty decision, the samples will be continued (Time 0, Time 2 hours, Time 4 hours, Time 6hours, Time 12 hours, Time 24 hours, so 6 samples of 1 ml). | Biological | patients with Delayed cerebral ischemia |
Primary outcome
S100B serum concentration after DCI suspicion.
Time frame: through study completion, an average of 2 year
S100B repeated samples, measure with an ELISA kit from ROCHE diagnostic. Measurement of the evolution of the S100B during at T0, T1h, T2h, T3h, T4h after the suspicion of DCI by the physician in charge. If an intravascular angioplasty procedure is performed S100B kinetic will be measured at T0, T2h, T4h, T6h, T12h and T24h after the procedure.
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 5 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Subarachnoid Hemorrhage, 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 4 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 5 Feb 2025. 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?
S100B serum concentration after DCI suspicion. (time frame: through study completion, an average of 2 year). 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 5 Feb 2025.