S100B Kinetic During the Occurrence and Treatment of Delayed Cerebral Ischaemia After a Subarachnoid Haemorrhage.

Subarachnoid Hemorrhage Clinical Trial

— SKinDCI  

Official title:

S100B Kinetic During the Occurrence and Treatment of Delayed Cerebral Ischaemia After a Subarachnoid Haemorrhage.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795362
• Other study ID #: 69HCL20_1081
• Secondary ID: 2021-A00048-33
• Status: Recruiting
• Start date: July 20, 2021
• Est. completion date: August 20, 2024

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: Baptiste BALANCA, MD PhD
• Phone: 04 72 35 75 76
• Email: baptiste.balanca[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 20, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Hemorrhage
• Ischemia
• Subarachnoid Hemorrhage

Intervention

Biological:
• blood sample
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).

Locations

Country	Name	City	State
France	Hopital Femme Mère Enfant	Bron
France	Hôpital Gabriel Montpied	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 2 year