A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage (LUCAS-IVH)

October 25, 2016 updated by: Dimitre Staykov, University of Erlangen-Nürnberg Medical School

Lumbar Drainage for Communicating Hydrocephalus After Intraventricular Hemorrhage: a Randomised, Controlled Trial(LUCAS-IVH: LUmbar CAtheter for Severe IntraVentricular Hemorrhage)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Neurology Department, University of Erlangen-Nuremberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Lumbar drainage
Procedure: Lumbar drainage
Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement of permanent VP-shunt
Time Frame: 14 days
if three attempts to clamp the EVD (control group) or LD (treatment group) fail, or overall extra-corporal drainage time exceeds 14 days, a VP-shunt is placed.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety aspects
Time Frame: during hospital stay
(i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation
during hospital stay
mortality and outcome
Time Frame: 3 and 6 months
modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

University of Freiburg

Investigators

  • Principal Investigator: Hagen Huttner, MD, Neurology Department, University of Erlangen-Nuremberg
  • Principal Investigator: Dimitre Staykov, MD, Neurology Department, University of Erlangen-Nuremberg
  • Study Chair: Jürgen Bardutzky, MD, University of Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (ESTIMATE)

January 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUCAS-IVH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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