CompletedPhase 3

EARLYdrain - Outcome After Early Lumbar CSF-drainage in Aneurysmal SAH

Germany300 participantsStarted 2011-01

Plain-language summary

The intention of the study is to investigate whether drainage of cerebral spinal fluid via a lumbar route ("Tuohy-drain") will improve outcome after intracranial aneurysmal subarachnoid hemorrhage (SAH).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age of 18 years or older * First aneurysmal SAH * Pre-morbid modified Rankin Scale score 0 or 1 * Aneurysm treatment performed in the first 48 hours after the initial hemorrhage. * Informed consent by the patient or his/her legal representative. In case neither the patient is capable of giving informed consent nor a legal representative is available, informed consent can be given by an independent physician neither involved in the patient´s treatment nor the trial (for specification see below) Exclusion Criteria: * Subarachnoid hemorrhage of other than aneurysmal origin * No hemorrhage visible on initial CCT scan (Fisher Grade I) * Pregnancy * Concurrent participation in another interventional trial (participation in an observational trial is allowed) * Life expectancy less than 1 year for other reasons than the actual SAH * Other concomitant severe disease that would confound with treatment * Other clear contraindication for treatment

What they're measuring

Disability in Lumbar drainage group (LD) vs. disability in control group (No-LD)

Timeframe: 6 months after SAH

Trial details

NCT IDNCT01258257

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

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