A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage

Phase 3CompletedNCT01041950

University of Erlangen-Nürnberg Medical School30 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intracerebral Hemorrhage Obstructive Hydrocephalus

Interventions

Lumbar drainagePROCEDURE

Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Neurology Department, University of Erlangen-Nuremberg

Erlangen, Germany

Outcomes

Primary Outcomes

Requirement of permanent VP-shunt

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.

Time frame: 14 days

Secondary Outcomes

Safety aspects

(i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation

Time frame: during hospital stay

mortality and outcome

modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.

Time frame: 3 and 6 months

Data from ClinicalTrials.gov

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