Brain Ischemia, Intracranial Vasospasm
Conditions
Keywords
Subarachnoid hemorrhage, delayed cerebral ischemia, external lumbar drainage, vasospasm
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.
Interventions
PROCEDUREexternal 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.
Sponsors
Elisabeth-TweeSteden Ziekenhuis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| dichotomized Glasgow outcome score (GOS) | at discharge, an expected average of 3 weeks after initial bleeding | Glasgow outcome scale was measured at discharge |
| 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. |
| 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. |
Countries
Netherlands
Outcome results
None listed