The Tilburg Vasospasm Study
- Conditions
- Brain IschemiaIntracranial Vasospasm
- Registration Number
- NCT01407614
- Lead Sponsor
- Elisabeth-TweeSteden Ziekenhuis
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical signs of delayed cerebral ischemia Patients will be followed for the duration of admission, an expected average of 3 weeks DCI was diagnosed when all of the following criteria were met: (1) the onset of new neurological deficits such as confusion, disorientation, drowsiness, or focal deficit during post-hemorrhage days (4 to 14); (2) negative findings on CT obtained to rule out other causes of neurological deterioration such as hemorrhage, cerebral edema, or hydrocephalus. (3) No other identifiable cause of neurological deterioration such as hyponatriemia, hypoxia, drug toxicity, infection, or seizures.
- Secondary Outcome Measures
Name Time Method dichotomized Glasgow outcome score (GOS) at discharge, an expected average of 3 weeks after initial bleeding Glasgow outcome scale was measured at discharge
new ischemic lesions on cerebral CT scan at 3 months after initial bleeding length of stay in intensive care unit Patients will be followed from initial admission until discharge, an expected average of 3 weeks The length of stay in the intensive care unit will be measured.
rebleeding rate of unsecured aneurysms and complications of external lumbar drainage Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days Evaluation of rebleeding rate of unsecured cerebral aneurysms during external lumbar drainage (ELD) of cerebrospinal fluid and evaluation of (other) complications of ELD such as (local)infection, discomfort/pain.
dichotomized Glasgow outcome score (GOS at 3 months after initial bleeding clinical signs of delayed cerebral ischemia At 3 months after initial bleeding As stated in first primary outcome measure 'clinical signs of cerebral ischemia' during admission.
Trial Locations
- Locations (1)
St Elisabeth Hospital
🇳🇱Tilburg, Brabant, Netherlands
St Elisabeth Hospital🇳🇱Tilburg, Brabant, Netherlands