Clinical trial NCT01407614: The Tilburg Vasospasm Study
Official title: Prevention of Secondary Ischemia After Aneurysmal Subarachnoid Hemorrhage With Cerebrospinal Fluid Drainage. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Brain Ischemia
Intracranial Vasospasm
Keywords: Subarachnoid hemorrhage
delayed cerebral ischemia
external lumbar drainage
vasospasm
Lead sponsor: Elisabeth-TweeSteden Ziekenhuis
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 with an aneurysmal subarachnoid hemorrhage.

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 presence of blood in the arachnoid space is likely. A wash out of blood and blood breakdown products in the cerebrospinal fluid (CSF) could reduce the incidence of vasospasm and DCI.

We aim to assess whether external lumbar drainage (ELD) of CSF is safe and reduces secondary ischemia and its sequelae.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Clinical signs of delayed cerebral ischemia
timeFrame: Patients will be followed for the duration of admission, an expected average of 3 weeks
Secondary outcomes:
measure: dichotomized Glasgow outcome score (GOS)
timeFrame: at discharge, an expected average of 3 weeks after initial bleeding
measure: new ischemic lesions on cerebral CT scan
timeFrame: at 3 months after initial bleeding
measure: length of stay in intensive care unit
timeFrame: Patients will be followed from initial admission until discharge, an expected average of 3 weeks
measure: rebleeding rate of unsecured aneurysms and complications of external lumbar drainage
timeFrame: Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days
measure: dichotomized Glasgow outcome score (GOS
timeFrame: at 3 months after initial bleeding
measure: clinical signs of delayed cerebral ischemia
timeFrame: At 3 months after initial bleeding
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: St Elisabeth Hospital
state: Brabant
Study officials:
affiliation: Elisabeth-TweeSteden Ziekenhuis
name: Paul Depauw, MD
role: PRINCIPAL_INVESTIGATOR
References: