Status:
TERMINATED
The Tilburg Vasospasm Study
Lead Sponsor:
Elisabeth-TweeSteden Ziekenhuis
Conditions:
Brain Ischemia
Intracranial Vasospasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
In a prospective randomized controlled trial, the investigators aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces delayed cerebral ischemia and its sequelae in patients w...
Detailed Description
Delayed cerebral ischemia (DCI) is a frequent complication after an aneurysmal subarachnoid hemorrhage (SAH). Its pathophysiological mechanism remains unclear but a role for cerebral vasospasm and the...
Eligibility Criteria
Inclusion
- spontaneous subarachnoid hemorrhage (SAH) with aneurysmal pattern graded as a Fisher grade III or higher on cerebral CT-scan.
- CSF drainage by external lumbar catheter can start within 96 hours after the initial SAH
- the drainage can start prior to the treatment of the ruptured aneurysm
- informed consent is signed by the patient or his representative
Exclusion
- spontaneous SAH with aneurysmal pattern graded as a Fisher grade I or II on CT and perimesencephalic hemorrhages
- traumatic SAH
- symptomatic hydrocephalus on admission necessitating drainage (EVD or ELD)
- the presence of a large intraventricular bloodclot in the third or fourth ventricle on CT
- the presence of a mass lesion with significant cerebral midline shift
- all patients whose neurological condition is too poor to allow clinical recognition of signs and symptoms of cerebral vasospasm. This includes all patients with a Hunt and Hess Grade V who failed to improve after initial resuscitation
- no informed consent
- mycotic aneurysms
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01407614
Start Date
December 1 2007
End Date
June 1 2009
Last Update
August 2 2011
Active Locations (1)
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1
St Elisabeth Hospital
Tilburg, North Brabant, Netherlands, 5022 GC