Use of Lumbar Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage.
Use of Lumbar Drain Versus Ventricular Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage (a Randomized Trial).
1 other identifier
interventional
20
1 country
1
Brief Summary
Recently, a clinical trial showed that the use of lumbar drains compared to ventricular drain in patients suffering from subarachnoid hemorrhage resulted in less delayed ischemic neurological deficits but failed to show a clinical benefit after 6 months. The underlying assumption was, that the cerebrospinal fluid (CSF) obtained from lumbar drains has a higher concentration of blood than CSF from lumbar drains. The investigators decided to test this assumption. In this study, the investigators will randomize patients to either placement of a ventricular or a lumbar drain and analyze the CSF drainage on a daily basis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2013
CompletedFirst Posted
Study publicly available on registry
June 26, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 21, 2014
October 1, 2014
2.8 years
June 9, 2013
October 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Accumulated Hb and bilirubin in CSF drainage
From drain placement to removal, in average 10 days.
Secondary Outcomes (3)
placement of a ventriculoperitoneal shunt
participants will be followed for the duration of hospital stay, in average 3 weeks
Lindegaard ratio (TCD) > 3
the participants will be followed for the duration of hospital stay, in average 3 weeks
clinical signs of vasospasms
The participants will be followedd for the duration of hospital stay, in average 3 weeks
Study Arms (2)
Lumbar drain group
EXPERIMENTALLumbar drain
Ventricular drain
ACTIVE COMPARATORVentricular drain
Interventions
Eligibility Criteria
You may qualify if:
- Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage
- In need for CSF drainage based on clinical judgment
You may not qualify if:
- intraventricular clots
- intraparenchymal clots causing midline shift
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurosurgery, Odense University Hospital
Odense, DK-5000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Birkeland, MD
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff surgeon
Study Record Dates
First Submitted
June 9, 2013
First Posted
June 26, 2013
Study Start
August 1, 2013
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
October 21, 2014
Record last verified: 2014-10