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

October 19, 2014 updated by: Peter Birkeland, Odense University Hospital

Use of Lumbar Drain Versus Ventricular Drain to Remove Clots in Patients Admitted to the Neuro-ICU After Subarachnoid Hemorrhage (a Randomized Trial).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, DK-5000
        • Recruiting
        • Department of Neurosurgery, Odense University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumbar drain group
Lumbar drain
Procedure: Lumbar drain
Active Comparator: Ventricular drain
Procedure: Ventricular drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accumulated Hb and bilirubin in CSF drainage
Time Frame: From drain placement to removal, in average 10 days.
From drain placement to removal, in average 10 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
placement of a ventriculoperitoneal shunt
Time Frame: participants will be followed for the duration of hospital stay, in average 3 weeks
participants will be followed for the duration of hospital stay, in average 3 weeks
Lindegaard ratio (TCD) > 3
Time Frame: the participants will be followed for the duration of hospital stay, in average 3 weeks
the participants will be followed for the duration of hospital stay, in average 3 weeks
clinical signs of vasospasms
Time Frame: The participants will be followedd for the duration of hospital stay, in average 3 weeks
The participants will be followedd for the duration of hospital stay, in average 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Peter Birkeland, MD, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

June 9, 2013

First Submitted That Met QC Criteria

June 23, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 19, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37238

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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