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

Subarachnoid Hemorrhage. Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01886521
• Other study ID #: 37238
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2013
• Last updated: October 19, 2014
• Start date: August 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage.

Intervention

Procedure:
• Lumbar drain

• Ventricular drain

Locations

Country	Name	City	State
Denmark	Department of Neurosurgery, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accumulated Hb and bilirubin in CSF drainage		From drain placement to removal, in average 10 days.	No
Secondary	placement of a ventriculoperitoneal shunt		participants will be followed for the duration of hospital stay, in average 3 weeks	No
Secondary	Lindegaard ratio (TCD) > 3		the participants will be followed for the duration of hospital stay, in average 3 weeks	No
Secondary	clinical signs of vasospasms		The participants will be followedd for the duration of hospital stay, in average 3 weeks	No