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

NCT04795362 | Completed

• 2 other identifiers: 69HCL20_10812021-A00048-33
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Subarachnoid Hemorrhage

Keywords

subarachnoid haemorrhage; S100B; Delayed cerebral ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Biological: blood sample

Interventions

blood sample BIOLOGICAL

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).

patients with Delayed cerebral ischemia

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

Adult patients hospitalized in neurological intensive care unit for subarachnoid hemorrhage, in whom the onset of delayed cerebral ischemia is suspected will be included.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hopital Femme Mère Enfant

Bron, 69500, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: July 20, 2021
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: February 5, 2025

Record last verified: 2024-04

Locations

FR (2)