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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:
University of Erlangen-Nürnberg Medical School
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: October 25, 2016
Last verified: October 2016
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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 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
COL4A1-related brain small-vessel disease
U.S. FDA Resources
Further study details as provided by Dimitre Staykov, University of Erlangen-Nürnberg Medical School:
Primary Outcome Measures:
- 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:
- 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.
| Enrollment: | 30 |
| Study Start Date: | May 2012 |
| Study Completion Date: | July 2015 |
| Primary Completion Date: | July 2015 (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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01041950
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
Study Data/Documents: Study Protocol
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | October 25, 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 |
ClinicalTrials.gov processed this record on August 18, 2017