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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
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
|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|