A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage (LUCAS-IVH)
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ClinicalTrials.gov Identifier: NCT01041950 |
Recruitment Status
:
Completed
First Posted
: January 5, 2010
Last Update Posted
: October 27, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intracerebral Hemorrhage Obstructive Hydrocephalus | Procedure: Lumbar drainage | Phase 2 Phase 3 |
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 |

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 |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041950
Germany | |
Neurology Department, University of Erlangen-Nuremberg | |
Erlangen, Germany, 91054 |
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 |
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 |
First Posted: | January 5, 2010 Key Record Dates |
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 |