EARLYdrain - Outcome After Early Lumbar CSF-drainage in Aneurysmal SAH (EARLYDRAIN)
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|ClinicalTrials.gov Identifier: NCT01258257|
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : February 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aneurysmal Subarachnoid Hemorrhage||Procedure: Insertion of a lumbar drain||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||EARLYdrain - Prospective Outcome Study of Early Lumbar Drainage in Aneurysmal Subarachnoid Hemorrhage|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2016|
Active Comparator: Lumbar drain (LD) / Tuohy drain
Intervention: Insertion of a lumbar drain All patients in the LD group receives a lumbar drain during anesthesia required for aneurysm treatment. Drainage of CSF is started after the post-procedural CT scan on day one after aneurysm securement.
Procedure: Insertion of a lumbar drain
In patients in the LD group, after insertion of the drain CSF is drained slowly and steadily at a rate of approximately 5 ml per hour. This leads to a planned daily CSF drainage of about 120 ml per day via lumbar route. To facilitate accuracy of drainage, regular drainage control every other hour and stopping in case of unwarranted excess drainage is strongly recommended by the principal investigators. In case of neurological decline suspiciously related to the lumbar drainage, the drain is closed immediately and may be gradually restarted after 12 to 24 hours, after performing a CCT scan. The drain is planned to remain in place until the control angiography on day 7 to 10 after the initial hemorrhage.
Other Name: Tuohy drain
No Intervention: No Lumbar drain (NoLD)
Patients randomized to the control group should not receive a lumbar drain before the planned control angiography to be performed on day 7 to 10 after SAH. If the patient develops hydrocephalus, and no EVD was placed initially for CSF drainage, a lumbar drain may be installed at the discretion of the local investigator. These patients are analyzed in the intention-to-treat analysis, but are not suitable for per-protocol analysis.
- Disability in Lumbar drainage group (LD) vs. disability in control group (No-LD) [ Time Frame: 6 months after SAH ]Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 2 versus 3 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit. Alternatively, a telephone questionnaire is suitable for outcome assessment of the modified Rankin Scale (13). Outcome assessment is planned to be done on the whole dataset as well as in preplanned stratified subsets (i.e. for example clinical SAH grade according to the Hunt&Hess scale 1-2 vs. 3-5 (14), CT grading according to Fisher I-III vs. IV (15)).
- mortality [ Time Frame: 6 months after SAH ]
- Modified Rankin scale (mRS) score as continuous variable [ Time Frame: 6 months after SAH ]
- Angiographically determined vasospasm [ Time Frame: once between day 7 to 9 after SAH ]Vasospasm here is defined as a caliber reduction by 33% or more on day 7-9 compared to the initial digital subtraction angiography.
- Vasospastic infarction [ Time Frame: last CT-scan during hospital stay, an expected average of 4 weeks ]
- Expression of clinical delayed neurological deficit [ Time Frame: day 1-14 after SAH ]
- Transcranial duplex ultrasound measured flow velocity in both middle cerebral arteries [ Time Frame: daily during hospital stay of the patient ]TCD-measured mean flow velocity in both MCA is determined daily at a depth of 50-60 mm.
- Early mortality [ Time Frame: Time span of initial hospital treatment after SAH, an expected average of 4 weeks ]
- Rate of CSF shunt insertion in the first six months [ Time Frame: First 6 months after SAH ]
- Presence of CSF infection [ Time Frame: First 14 days after SAH ]Infection in this case is defined by the modified criteria for device-associated (CDC) meningitis (treatment required on either positive culture, or elevated cell count, red cell/ white cell ratio, increased lactate and/or decreased glucose)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258257
|Charité University Medicine Department of Neurosurgery Campus Virchow Klinikum|
|Berlin, Germany, 13353|
|Principal Investigator:||Stefan Wolf, Dr.||Charite University medicine / department of neurosurgery|