Back to results

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

Primary Purpose

Subarachnoid Hemorrhage.

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Lumbar drain

Ventricular drain

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Neurosurgery, Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumbar drain group

Ventricular drain

Arm Description

Lumbar drain

Ventricular drain

Outcomes

Primary Outcome Measures

Accumulated Hb and bilirubin in CSF drainage

Secondary Outcome Measures

placement of a ventriculoperitoneal shunt

Lindegaard ratio (TCD) > 3

clinical signs of vasospasms

Full Information

NCT ID

NCT01886521

First Posted

June 9, 2013

Last Updated

October 19, 2014

Sponsor

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01886521

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

August 2013 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Odense University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subarachnoid Hemorrhage.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lumbar drain group

Arm Type

Experimental

Arm Description

Lumbar drain

Arm Title

Ventricular drain

Arm Type

Active Comparator

Arm Description

Ventricular drain

Intervention Type

Procedure

Intervention Name(s)

Lumbar drain

Intervention Type

Procedure

Intervention Name(s)

Ventricular drain

Primary Outcome Measure Information:

Title

Accumulated Hb and bilirubin in CSF drainage

Time Frame

From drain placement to removal, in average 10 days.

Secondary Outcome Measure Information:

Title

placement of a ventriculoperitoneal shunt

Time Frame

participants will be followed for the duration of hospital stay, in average 3 weeks

Title

Lindegaard ratio (TCD) > 3

Time Frame

the participants will be followed for the duration of hospital stay, in average 3 weeks

Title

clinical signs of vasospasms

Time Frame

The participants will be followedd for the duration of hospital stay, in average 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Birkeland, MD

Organizational Affiliation

Odense University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Neurosurgery, Odense University Hospital

City

Odense

ZIP/Postal Code

DK-5000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Birkeland, MD

Phone

+4560869248

Peter@Birkeland.dk

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs