The Tilburg Vasospasm Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Secondary Ischemia After Aneurysmal Subarachnoid Hemorrhage With Cerebrospinal Fluid Drainage. A Randomized Controlled Trial

Conditions
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Brain Ischemia, Intracranial Vasospasm

Intervention / Treatment
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* Procedure: external lumbar drainage (ELD) of cerebrospinal fluid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: external lumbar drainage<br>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<br>* 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.<br>|
| No Intervention: No intervention<br>In this arm the patients received standard treatment following protocol for patients with subarachnoid hemorrhage | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical signs of delayed cerebral ischemia | 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. | Patients will be followed for the duration of admission, an expected average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dichotomized Glasgow outcome score (GOS) | Glasgow outcome scale was measured at discharge | at discharge, an expected average of 3 weeks after initial bleeding | 
| new ischemic lesions on cerebral CT scan |  | at 3 months after initial bleeding | 
| length of stay in intensive care unit | The length of stay in the intensive care unit will be measured. | Patients will be followed from initial admission until discharge, an expected average of 3 weeks | 
| rebleeding rate of unsecured aneurysms and complications of external lumbar drainage | 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. | Patients willl be followed from initial bleeding until treatment of aneurysm, an expected average of 3 days | 
| dichotomized Glasgow outcome score (GOS |  | at 3 months after initial bleeding | 
| clinical signs of delayed cerebral ischemia | As stated in first primary outcome measure 'clinical signs of cerebral ischemia' during admission. | At 3 months after initial bleeding | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subarachnoid hemorrhage, delayed cerebral ischemia, external lumbar drainage, vasospasm