Use of Lumbar Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage.

NCT ID: NCT01886521

Last Updated: 2014-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Subarachnoid Hemorrhage.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lumbar drain group

Lumbar drain

Group Type EXPERIMENTAL

Lumbar drain

Intervention Type PROCEDURE

Ventricular drain

Ventricular drain

Group Type ACTIVE_COMPARATOR

Ventricular drain

Intervention Type PROCEDURE

Interventions

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Lumbar drain

Intervention Type PROCEDURE

Ventricular drain

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to the neuro-ICU with aneurysmal subarachnoid hemorrhage
* In need for CSF drainage based on clinical judgment

Exclusion Criteria

* intraventricular clots
* intraparenchymal clots causing midline shift
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter Birkeland

Staff surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Birkeland, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Department of Neurosurgery, Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Peter Birkeland, MD

Role: primary

+4560869248

Other Identifiers

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37238

Identifier Type: -

Identifier Source: org_study_id

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