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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01886521
Enrollment
20
Registered
2013-06-26
Start date
2013-08-31
Completion date
2016-09-30
Last updated
2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage.

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.

Interventions

PROCEDURELumbar drain
PROCEDUREVentricular drain

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Accumulated Hb and bilirubin in CSF drainageFrom drain placement to removal, in average 10 days.

Secondary

MeasureTime frame
placement of a ventriculoperitoneal shuntparticipants will be followed for the duration of hospital stay, in average 3 weeks
Lindegaard ratio (TCD) > 3the participants will be followed for the duration of hospital stay, in average 3 weeks
clinical signs of vasospasmsThe participants will be followedd for the duration of hospital stay, in average 3 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026