Use of Lumbar Drain to Remove Clots in Patients Admitted... | NCT01886521

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

NCT01886521

Sponsor

Odense University Hospital

Status

Unknown status

Last Update Posted

Oct 21, 2014Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Subarachnoid Hemorrhage.

Interventions

Lumbar drain
Ventricular drain

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Jun 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Jun 9, 2013

First Submission Date that Met QC Criteria

Jun 23, 2013

First Posted Date

Jun 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2014

Last Update Posted Date

Oct 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lumbar drain group	Experimental	Lumbar drain	Procedure: Lumbar drain
Ventricular drain	Active Comparator	Ventricular drain	Procedure: Ventricular drain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lumbar drain	Procedure		Lumbar drain group
Ventricular drain

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Birkeland, MD	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery, Odense University Hospital	Recruiting	Odense		DK-5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided