Clinical trial NCT01041950: A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Intracerebral Hemorrhage
Obstructive Hydrocephalus
Keywords: intracerebral hemorrhage
intraventricular hemorrhage
hydrocephalus
Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: University of Freiburg
First posted: 2010-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Requirement of permanent VP-shunt
timeFrame: 14 days
Secondary outcomes:
measure: Safety aspects
timeFrame: during hospital stay
measure: mortality and outcome
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Neurology Department, University of Erlangen-Nuremberg
Study officials:
affiliation: Neurology Department, University of Erlangen-Nuremberg
name: Hagen Huttner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Department, University of Erlangen-Nuremberg
name: Dimitre Staykov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Freiburg
name: Jürgen Bardutzky, MD
role: STUDY_CHAIR
References:
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.