Back to resultsA Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage (LUCAS-IVH)
Primary Purpose
Intracerebral Hemorrhage, Obstructive Hydrocephalus
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Lumbar drainage
Sponsored by
About this trial
This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring intracerebral hemorrhage, intraventricular hemorrhage, hydrocephalus, Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus
Eligibility 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
Sites / Locations
- Neurology Department, University of Erlangen-Nuremberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lumbar drainage
Control
Arm Description
Outcomes
Primary Outcome Measures
Requirement of permanent VP-shunt
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
(i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation
mortality and outcome
modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.
Full Information
NCT ID
NCT01041950
First Posted
January 4, 2010
Last Updated
October 25, 2016
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
University of Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT01041950
Brief Title
A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage
Acronym
LUCAS-IVH
Official Title
Lumbar Drainage for Communicating Hydrocephalus After Intraventricular Hemorrhage: a Randomised, Controlled Trial(LUCAS-IVH: LUmbar CAtheter for Severe IntraVentricular Hemorrhage)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
University of Freiburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage, Obstructive Hydrocephalus
Keywords
intracerebral hemorrhage, intraventricular hemorrhage, hydrocephalus, Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumbar drainage
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Lumbar drainage
Intervention Description
Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.
Primary Outcome Measure Information:
Title
Requirement of permanent VP-shunt
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Safety aspects
Description
(i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation
Time Frame
during hospital stay
Title
mortality and outcome
Description
modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.
Time Frame
3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagen Huttner, MD
Organizational Affiliation
Neurology Department, University of Erlangen-Nuremberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dimitre Staykov, MD
Organizational Affiliation
Neurology Department, University of Erlangen-Nuremberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jürgen Bardutzky, MD
Organizational Affiliation
University of Freiburg
Official's Role
Study Chair
Facility Information:
Facility Name
Neurology Department, University of Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27888608
Citation
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.
Results Reference
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A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage
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