Status:
COMPLETED
EARLYdrain - Outcome After Early Lumbar CSF-drainage in Aneurysmal SAH
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Aneurysmal Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (SA...
Detailed Description
1. Introduction Patients suffering from aneurysmal subarachnoid hemorrhage (SAH) are predominantly threatened by two distinct medical problems. Firstly, they may experience a second - and often mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01258257
Start Date
January 1 2011
End Date
September 1 2016
Last Update
February 3 2017
Active Locations (1)
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1
Charité University Medicine Department of Neurosurgery Campus Virchow Klinikum
Berlin, State of Berlin, Germany, 13353