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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Freiburg
Information provided by (Responsible Party):
Dimitre Staykov, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01041950
First received: January 4, 2010
Last updated: July 1, 2014
Last verified: July 2014
History of Changes
  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
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:

U.S. FDA Resources

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 and Barthel index 3 and 6 months after treatment, as well as in-hospital mortality.
Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • supratentorial intracerebral hemorrhage <60ml (including anticoagulant- related ICH)
  • 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 4, 2010
Last Updated: July 1, 2014
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on March 03, 2015