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

Intracerebral Hemorrhage Clinical Trial

— LUCAS-IVH  

Official title:

Lumbar Drainage for Communicating Hydrocephalus After Intraventricular Hemorrhage: a Randomised, Controlled Trial(LUCAS-IVH: LUmbar CAtheter for Severe IntraVentricular Hemorrhage)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041950
• Other study ID #: LUCAS-IVH
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 4, 2010
• Last updated: October 25, 2016
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hydrocephalus
• Intracerebral Hemorrhage
• Obstructive Hydrocephalus

Intervention

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

Locations

Country	Name	City	State
Germany	Neurology Department, University of Erlangen-Nuremberg	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	University of Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days	No
Secondary	Safety aspects	(i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation	during hospital stay	Yes
Secondary	mortality and outcome	modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.	3 and 6 months	No