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

Phase 2

Completed

• Conditions: Intracerebral Hemorrhage; Obstructive Hydrocephalus
• Interventions: Procedure: Lumbar drainage

• Registration Number: NCT01041950
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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).

Study Timeline

• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Study Start: 2012-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar drainage	Lumbar drainage	-

Primary Outcome Measures

Name	Time	Method
Requirement of permanent VP-shunt	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.

Secondary Outcome Measures

Name	Time	Method
Safety aspects	during hospital stay	(i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation
mortality and outcome	3 and 6 months	modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.

Trial Locations

Locations (1)

Neurology Department, University of Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany