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EARLYdrain - Outcome After Early Lumbar CSF-drainage in Aneurysmal SAH (EARLYDRAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01258257
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):
Dr. Stefan Wolf, Charite University, Berlin, Germany

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 (SAH).

Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Procedure: Insertion of a lumbar drain Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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)).

Secondary Outcome Measures :
  1. mortality [ Time Frame: 6 months after SAH ]
  2. Modified Rankin scale (mRS) score as continuous variable [ Time Frame: 6 months after SAH ]
  3. 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.

  4. Vasospastic infarction [ Time Frame: last CT-scan during hospital stay, an expected average of 4 weeks ]
  5. Expression of clinical delayed neurological deficit [ Time Frame: day 1-14 after SAH ]
  6. 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.

  7. Early mortality [ Time Frame: Time span of initial hospital treatment after SAH, an expected average of 4 weeks ]
  8. Rate of CSF shunt insertion in the first six months [ Time Frame: First 6 months after SAH ]
  9. 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)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01258257

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Charité University Medicine Department of Neurosurgery Campus Virchow Klinikum
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Stefan Wolf, Dr. Charite University medicine / department of neurosurgery

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Stefan Wolf, Stefan Wolf, MD, Charite University, Berlin, Germany Identifier: NCT01258257     History of Changes
Other Study ID Numbers: EARLYDRAIN
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Full anonymized data is planned to be shared among collaborators.
Keywords provided by Dr. Stefan Wolf, Charite University, Berlin, Germany:
Subarachnoid hemorrhage
Lumbar drain
Cerebral vasospasm
Cerebral Ventricles
Cerebrospinal Fluid
Prospective Studies
Subarachnoid Hemorrhage/cerebrospinal fluid*
Subarachnoid Hemorrhage/complications*
Subarachnoid Space/surgery*
Vasospasm, Intracranial/etiology
Vasospasm, Intracranial/surgery*
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases