A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage (LUCAS-IVH)

University of Erlangen-Nürnberg Medical School

Status and phase

Completed

Phase 3

Phase 2

Conditions

Obstructive Hydrocephalus

Intracerebral Hemorrhage

Treatments

Procedure: Lumbar drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT01041950

LUCAS-IVH

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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