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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01041950
First Posted: January 5, 2010
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Freiburg
Information provided by (Responsible Party):
Dimitre Staykov, University of Erlangen-Nürnberg Medical School
  Purpose
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.

Condition Intervention Phase
Intracerebral Hemorrhage Obstructive Hydrocephalus Procedure: Lumbar drainage Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lumbar Drainage for Communicating Hydrocephalus After Intraventricular Hemorrhage: a Randomised, Controlled Trial(LUCAS-IVH: LUmbar CAtheter for Severe IntraVentricular Hemorrhage)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dimitre Staykov, University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Safety aspects [ Time Frame: during hospital stay ]
    (i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation

  • mortality and outcome [ Time Frame: 3 and 6 months ]
    modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.
Enrollment: 30
Study Start Date: May 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lumbar drainage Procedure: Lumbar drainage
Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.
No Intervention: Control

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041950


Locations
Germany
Neurology Department, University of Erlangen-Nuremberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
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
  More Information

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dimitre Staykov, Priv.-Doz. Dr. med., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01041950     History of Changes
Other Study ID Numbers: LUCAS-IVH
First Submitted: January 4, 2010
First Posted: January 5, 2010
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by Dimitre Staykov, University of Erlangen-Nürnberg Medical School:
intracerebral hemorrhage
intraventricular hemorrhage
hydrocephalus
Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Hydrocephalus
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases