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A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage

NCT ID: NCT01041950

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to determine if usage of early lumbar drainage leads to less shunt surgery and less catheter associated complications in patients with communicating hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.

Detailed Description

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All patients requiring external ventricular drain (EVD) for treatment of acute obstructive hydrocephalus receive intraventricular fibrinolysis with rt-PA via the ventricular catheter. Lumbar drainage (LD) is inserted at a timepoint, when communication between the internal and the external CSF-spaces is recognizable on CT ("opening" of third and fourth ventricle and aqueduct).

Conditions

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Intracerebral Hemorrhage Obstructive Hydrocephalus

Keywords

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intracerebral hemorrhage intraventricular hemorrhage hydrocephalus Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lumbar drainage

Group Type EXPERIMENTAL

Lumbar drainage

Intervention Type PROCEDURE

Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lumbar drainage

Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* supratentorial intracerebral hemorrhage \<60ml
* intraventricular hemorrhage with casting of the third and fourth ventricles
* obstructive hydrocephalus with need of external ventricular drainage
* GCS \<9 on admission or within 48h of symptom onset
* admission within 48h of symptom onset
* preceding modified Rankin scale ≤3
* age 18-85 years

Exclusion Criteria

* ICH related to oral anticoagulation, trauma, tumor, arteriovenous malformation, aneurysm, systemic thrombolysis or sinus thrombosis
* infratentorial hemorrhage
* pregnancy
* admission 48h after symptom onset
* preceding modified Rankin scale \>3
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Freiburg

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Dimitre Staykov

Priv.-Doz. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hagen Huttner, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department, University of Erlangen-Nuremberg

Dimitre Staykov, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology Department, University of Erlangen-Nuremberg

Jürgen Bardutzky, MD

Role: STUDY_CHAIR

University of Freiburg

Locations

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Neurology Department, University of Erlangen-Nuremberg

Erlangen, , Germany

Site Status

Countries

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Germany

References

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Staykov D, Kuramatsu JB, Bardutzky J, Volbers B, Gerner ST, Kloska SP, Doerfler A, Schwab S, Huttner HB. Efficacy and safety of combined intraventricular fibrinolysis with lumbar drainage for prevention of permanent shunt dependency after intracerebral hemorrhage with severe ventricular involvement: A randomized trial and individual patient data meta-analysis. Ann Neurol. 2017 Jan;81(1):93-103. doi: 10.1002/ana.24834.

Reference Type DERIVED
PMID: 27888608 (View on PubMed)

Other Identifiers

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LUCAS-IVH

Identifier Type: -

Identifier Source: org_study_id