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

This study is currently recruiting participants.
Verified May 2013 by University of Erlangen-Nürnberg Medical School
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: May 3, 2013
Last verified: May 2013

January 4, 2010
May 3, 2013
June 2010
December 2013   (final data collection date for primary outcome measure)
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.
modified Rankin scale and Barthel index [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01041950 on ClinicalTrials.gov Archive Site
  • 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.
  • Incidence of permanent hydrocephalus with need of shunt surgery [ Time Frame: discharge, 3 and 6 months ] [ Designated as safety issue: No ]
  • Incidence of catheter associated complications [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Dimitre Staykov, MD +49-9131-8544539 dimitre.staykov@uk-erlangen.de
Contact: Hagen Huttner, MD +49-9131-8544523 hagen.huttner@uk-erlangen.de
Germany
 
NCT01041950
LUCAS-IVH
No
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
May 2013

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