Clinical Trials Directory

Trials / Completed

CompletedNCT04795362

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

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BIOLOGICALblood 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).

Timeline

Start date
2021-07-20
Primary completion
2024-06-17
Completion
2024-06-17
First posted
2021-03-12
Last updated
2025-02-05

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04795362. Inclusion in this directory is not an endorsement.