The Tilburg Vasospasm Study
|ClinicalTrials.gov Identifier: NCT01407614|
Recruitment Status : Terminated (patient enrollment too slow)
First Posted : August 2, 2011
Last Update Posted : August 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Brain Ischemia Intracranial Vasospasm||Procedure: external lumbar drainage (ELD) of cerebrospinal fluid||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prevention of Secondary Ischemia After Aneurysmal Subarachnoid Hemorrhage With Cerebrospinal Fluid Drainage. A Randomized Controlled Trial|
|Study Start Date :||December 2007|
|Primary Completion Date :||March 2009|
|Study Completion Date :||June 2009|
Active Comparator: external lumbar drainage
Within 96 hours of initial subarachnoid hemorrhage, patients were randomized for external lumbar drainage (ELD)of cerebrospinal fluid during a maximum of 7 days or standard treatment of subarachnoid hemorrhage without ELD
Procedure: external lumbar drainage (ELD) of cerebrospinal fluid
Patients were randomized for external lumbar drainage of cerebrospinal fluid or standard treatment of a subarachnoid hemorrhage alone. External drainage was started within 96 hours of initial subarachnoid hemorrhage during 7 days at a maximum of 5-10 ml/hour.
No Intervention: No intervention
In this arm the patients received standard treatment following protocol for patients with subarachnoid hemorrhage
- Clinical signs of delayed cerebral ischemia [ Time Frame: 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.
- dichotomized Glasgow outcome score (GOS) [ Time Frame: 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 [ Time Frame: at 3 months after initial bleeding ]
- length of stay in intensive care unit [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at 3 months after initial bleeding ]
- clinical signs of delayed cerebral ischemia [ Time Frame: At 3 months after initial bleeding ]As stated in first primary outcome measure 'clinical signs of cerebral ischemia' during admission.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407614
|St Elisabeth Hospital|
|Tilburg, Brabant, Netherlands, 5022 GC|
|Principal Investigator:||Paul Depauw, MD||Elisabeth-TweeSteden Ziekenhuis|