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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| external lumbar drainage | Active Comparator | 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 |
|
| No intervention | No Intervention | In this arm the patients received standard treatment following protocol for patients with subarachnoid hemorrhage |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| external lumbar drainage (ELD) of cerebrospinal fluid | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Depauw, MD | Elisabeth-TweeSteden Ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Elisabeth Hospital | Tilburg | North Brabant | 5022 GC | Netherlands |
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D020301 | Vasospasm, Intracranial |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |