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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Intracerebral Hemorrhage; Obstructive Hydrocephalus	Procedure: Lumbar drainage	Phase 2; Phase 3

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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
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)
Study Start Date :	May 2012
Actual Primary Completion Date :	July 2015
Actual Study Completion Date :	July 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. Safety aspects [ Time Frame: during hospital stay ]
   (i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation
2. mortality and outcome [ Time Frame: 3 and 6 months ]
   modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.

Eligibility Criteria

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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

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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

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Study Data/Documents: Study Protocol 

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

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.

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 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