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

Not Applicable

• Conditions: Subarachnoid Hemorrhage.
• Interventions: Procedure: Lumbar drain; Procedure: Ventricular drain

• Registration Number: NCT01886521
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-09
• Study First Submitted QC: 2013-06-23
• Study First Posted: 2013-06-26
• Study Start: 2013-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-19
• Last Update Posted: 2014-10-21
• Primary Completion: 2016-06
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

• intraventricular clots
• intraparenchymal clots causing midline shift
• pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar drain group	Lumbar drain	Lumbar drain
Ventricular drain	Ventricular drain	Ventricular drain

Primary Outcome Measures

Name	Time	Method
Accumulated Hb and bilirubin in CSF drainage	From drain placement to removal, in average 10 days.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Neurosurgery, Odense University Hospital; 🇩🇰 Odense, Denmark