A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage (LUCAS-IVH)
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.
Procedure: Lumbar drainage
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)|
- Requirement of permanent VP-shunt [ Time Frame: 14 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ](i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation
- mortality and outcome [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]modified Rankin Scale and Barthel index 3 and 6 months after treatment, as well as in-hospital mortality.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|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|
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).
|Contact: Dimitre Staykov, MDfirstname.lastname@example.org|
|Contact: Hagen Huttner, MDemail@example.com|
|Neurology Department, University of Erlangen-Nuremberg||Recruiting|
|Erlangen, Germany, 91054|
|Contact: Dimitre Staykov, MD +49-9131-8544539 firstname.lastname@example.org|
|Contact: Jürgen Bardutzky, MD +49-9131-8544556 email@example.com|
|Principal Investigator: Juergen Bardutzky, MD|
|Sub-Investigator: Dimitre Staykov, MD|
|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|