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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.
University of Freiburg
Information provided by (Responsible Party):
Dimitre Staykov, University of Erlangen-Nürnberg Medical School Identifier:
First received: January 4, 2010
Last updated: October 25, 2016
Last verified: October 2016
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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

Primary Outcome Measures:
  • Requirement of permanent VP-shunt [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    (i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation

  • mortality and outcome [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    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).

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01041950

Neurology Department, University of Erlangen-Nuremberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
University of Freiburg
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 site

Responsible Party: Dimitre Staykov, Priv.-Doz. Dr. med., University of Erlangen-Nürnberg Medical School Identifier: NCT01041950     History of Changes
Other Study ID Numbers: LUCAS-IVH 
Study First Received: January 4, 2010
Last Updated: October 25, 2016
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Cerebral Hemorrhage
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases processed this record on October 27, 2016