Cerebral Vasospasm Clinical Trial
— CVSBIODIAGOfficial title:
Predictive Model for the Occurrence of Cerebral Vasospasm Complicating Subarachnoid Haemorrhage by Combined Analysis of the Kinetics of a Panel of Biomarkers.
NCT number | NCT06303349 |
Other study ID # | CHUBX 2023/45 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2024 |
Est. completion date | June 2025 |
The objective is to create a dynamic clinical prediction model that includes routinely measured care and biological biomarkers to predict cerebral vasospasm within 14 days of bleeding in patients treated in the neurosurgical intensive care unit for subarachnoid hemorrhage. Patients admitted to intensive care will be followed for up to 14 days (D14 time horizon of interest), or until discharge from intensive care if earlier. Blood samples will be taken from D1 to D10 to isolate the blood biomarkers of interest for each patient. The measurement of biomarkers and cerebral vasospasm will be blinded to each other.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subarachnoid hemorrhage (of aneurysmal or non-aneurysmal etiology) less than 4 days prior to admission to neuro-resuscitation, diagnosed on clinical presentation and confirmed by brain imaging. - Free, informed and written consent signed by the patient (or, failing this, his or her representative). - Patient entitled to or affiliated with social security Exclusion Criteria: - Significant vasospasm on admission to the department, diagnosed on initial imaging - Patient whose short-term survival (48 hours) appears compromised - Contraindication to perfusion CT scan - Pregnant or breast-feeding women - Patient under legal protection (persons deprived of liberty or under guardianship) |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux | Bordeaux University |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of cerebral vasospasm | Occurrence of cerebral vasospasm within 14 days of ICU (Intensive Care Unit) admission. | Day 14 after inclusion | |
Secondary | Biomarkers measurements | Daily Serum measurements of the following markers from D1 to D10:
IL-6 NSE S100 ß |
Day 10 after inclusion | |
Secondary | WFNS (World Federation of Neurologic Surgeons) score | Initial WFNS score : From grade I (13% of bad evolution at 6 months) to grade V (68% of bad evolution à 6 months) | up to Day 10 after inclusion | |
Secondary | Glasgow score | Hourly Glasgow score (scale from 3 :deep coma to 15 : fully conscious) | up to Day 10 after inclusion | |
Secondary | Medical Research Council (MRC) score | Presence and intensity (MRC score) of motor deficit. scale from 0 : no movement is observed to 5 : full range of motion | up to Day 10 after inclusion | |
Secondary | PtiO2 (oxygen pressure in the cerebral tissue) | Hourly PtiO2 data. | up to Day 10 after inclusion | |
Secondary | Transcranial Doppler | Daily transcranial Doppler data from D1 to D10; | up to Day 10 after inclusion | |
Secondary | Modified Fisher score | Modified Fisher score from initial imaging. Scale from 0(no subarachnoid hemorrhage / no intraventricular hemorrhage / incidence of symptomatic vasospasm: 0%) to 4 (thick subarachnoid hemorrhage / intraventricular hemorrhagepresent /the incidence of symptomatic vasospasm: 40%) | up to Day 10 after inclusion | |
Secondary | Non-significant angiographic vasospasm | Presence of non-significant angiographic vasospasm on initial diagnostic/therapeutic arteriography or on follow-up imaging from D1 to D10. | up to Day 10 after inclusion | |
Secondary | Non-significant perfusion anomaly | Presence of a non-significant perfusion anomaly on follow-up imaging from D1 to D10. | up to Day 10 after inclusion | |
Secondary | Glasgow Outcome Scale -Extended (GOS-E) | GOS-E at ICU discharge. 8 levels (1 to 8) are in the scale: Minimum Score = 1 : Dead Maximum Score = 8 : Upper Good Recovery | up to Day 14 after inclusion | |
Secondary | Cerebral ischemic lesions | Presence of delayed cerebral ischemic lesions on last imaging before discharge. | up to Day 14 after inclusion | |
Secondary | Occurrence of symptomatic vasospasm | Occurrence of symptomatic vasospasm in non-severe SAH during ICU stay. | up to Day 14 after inclusion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02275949 -
Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage
|
N/A | |
Completed |
NCT02389634 -
Identification of Novel Molecular Markers for Vasospasm
|
||
Completed |
NCT00962546 -
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
|
N/A | |
Not yet recruiting |
NCT04512859 -
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
|
N/A | |
Completed |
NCT01024972 -
Safety Study of Dantrolene in Subarachnoid Hemorrhage
|
Phase 1/Phase 2 | |
Completed |
NCT00692744 -
Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)
|
N/A | |
Completed |
NCT04208477 -
"The Effect of Stellate Ganglion Block in Severe Brain Injury"
|
N/A | |
Recruiting |
NCT02129413 -
Safety Study of Carotid Body Neurostimulation to Treat Cerebral Vasospasm
|
N/A | |
Terminated |
NCT00487461 -
Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage
|
N/A | |
Terminated |
NCT00582868 -
Use of Brain Oxygen Tension Level and Cleaved-tau Protein to Detect Vasospasm After SAH
|
N/A | |
Withdrawn |
NCT01878136 -
Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
|
Phase 1/Phase 2 | |
Withdrawn |
NCT01091870 -
Sildenafil for Prevention of Cerebral Vasospasm
|
Phase 2 | |
Completed |
NCT03214705 -
Role of CT Perfusion in Predicting Poor Outcome After Subarachnoid Hemorrhage
|
||
Recruiting |
NCT05150002 -
Cervical Spinal Cord Stimulation in Patients With Cerebral Vasospasm After Subarachnoid Haemorrhage: VasoStim Study
|
N/A | |
Completed |
NCT01187420 -
Bilateral Bispectral Index (BIS) Study
|
N/A | |
Enrolling by invitation |
NCT05230134 -
Cervical Sympathetic Block in Patients With Cerebral Vasospasm
|
N/A | |
Withdrawn |
NCT02426827 -
Cervical Spinal Cord Stimulation in Cerebral Vasospasm
|
N/A | |
Withdrawn |
NCT00871065 -
Safety Study of Sildenafil in Treatment of Cerebral Aneurysm Vasospasm
|
Phase 2 | |
Recruiting |
NCT04691271 -
Stellate Ganglion Block and Cerebral Vasospasm
|
N/A | |
Recruiting |
NCT02432157 -
Safety and Feasibility of Hypertonic Saline Solution After Aneurysmal Subarachnoid Hemorrhage:
|
Phase 1/Phase 2 |