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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
January 4, 2010
January 5, 2010
October 27, 2016
May 2012
July 2015   (Final data collection date for primary outcome measure)
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.
modified Rankin scale and Barthel index [ Time Frame: 3 and 6 months ]
Complete list of historical versions of study NCT01041950 on ClinicalTrials.gov Archive Site
  • 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.
  • Incidence of permanent hydrocephalus with need of shunt surgery [ Time Frame: discharge, 3 and 6 months ]
  • Incidence of catheter associated complications [ Time Frame: during treatment ]
Not Provided
Not Provided
 
A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage
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.
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).
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Intracerebral Hemorrhage
  • Obstructive Hydrocephalus
Procedure: Lumbar drainage
Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.
  • Experimental: Lumbar drainage
    Intervention: Procedure: Lumbar drainage
  • No Intervention: Control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01041950
LUCAS-IVH
No
Not Provided
Not Provided
Dimitre Staykov, University of Erlangen-Nürnberg Medical School
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
University of Erlangen-Nürnberg Medical School
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP