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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01258257
First received: December 9, 2010
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Aneurysmal Subarachnoid Hemorrhage
Procedure: Insertion of a lumbar drain
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EARLYdrain - Prospective Outcome Study of Early Lumbar Drainage in Aneurysmal Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Disability in Lumbar drainage group (LD) vs. disability in control group (No-LD) [ Time Frame: 6 months after SAH ] [ Designated as safety issue: Yes ]
    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:
  • mortality [ Time Frame: 6 months after SAH ] [ Designated as safety issue: Yes ]
  • Modified Rankin scale (mRS) score as continuous variable [ Time Frame: 6 months after SAH ] [ Designated as safety issue: Yes ]
  • Angiographically determined vasospasm [ Time Frame: once between day 7 to 9 after SAH ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Expression of clinical delayed neurological deficit [ Time Frame: day 1-14 after SAH ] [ Designated as safety issue: Yes ]
  • Transcranial duplex ultrasound measured flow velocity in both middle cerebral arteries [ Time Frame: daily during hospital stay of the patient ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Rate of CSF shunt insertion in the first six months [ Time Frame: First 6 months after SAH ] [ Designated as safety issue: Yes ]
  • Presence of CSF infection [ Time Frame: First 14 days after SAH ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 300
Study Start Date: December 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lumbar drain (LD) / Tuohy 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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258257

Contacts
Contact: Stefan Wolf, Dr. 0049-30-450-660 ext 515 Stefan.Wolf@charite.de
Contact: Eric Jüttler, Prof. 0049-30-450-660 ext 615 Eric.Juettler@charite.de

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Stefan Wolf, attending doctor/Department of Neurosurgery/Charité
ClinicalTrials.gov Identifier: NCT01258257     History of Changes
Other Study ID Numbers: EARLYDRAIN
Study First Received: December 9, 2010
Last Updated: August 19, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Aneurysm
Subarachnoid hemorrhage
Lumbar drain
Cerebral vasospasm
Cerebral Ventricles
Cerebrospinal Fluid
Prospective Studies
Drainage/methods*
Humans
Subarachnoid Hemorrhage/cerebrospinal fluid*
Subarachnoid Hemorrhage/complications*
Subarachnoid Space/surgery*
Vasospasm, Intracranial/etiology
Vasospasm, Intracranial/surgery*

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014