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

U

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

Trial design

30 participants in 2 patient groups

Lumbar drainage
Experimental group
Treatment:
Procedure: Lumbar drainage
Control
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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