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

This study has been completed.

Sponsor:

Collaborator:

University of Freiburg

Information provided by (Responsible Party):

Dimitre Staykov, University of Erlangen-Nürnberg Medical School

ClinicalTrials.gov Identifier:

NCT01041950

First received: January 4, 2010

Last updated: June 23, 2016

Last verified: June 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Intracerebral Hemorrhage Obstructive Hydrocephalus	Procedure: Lumbar drainage	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Lumbar Drainage for Communicating Hydrocephalus After Intraventricular Hemorrhage: a Randomised, Controlled Trial(LUCAS-IVH: LUmbar CAtheter for Severe IntraVentricular Hemorrhage)

Resource links provided by NLM:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

MedlinePlus related topics: Bleeding Hydrocephalus

Genetic and Rare Diseases Information Center resources: Hydrocephalus

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:

Requirement of permanent VP-shunt [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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:

Safety aspects [ Time Frame: during hospital stay ] [ Designated as safety issue: Yes ]
(i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation
mortality and outcome [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.


Enrollment:	30
Study Start Date:	May 2012
Study Completion Date:	July 2015
Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lumbar drainage	Procedure: Lumbar drainage Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.
No Intervention: Control

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).

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041950

Locations


Germany
Neurology Department, University of Erlangen-Nuremberg
Erlangen, Germany, 91054

Sponsors and Collaborators

University of Erlangen-Nürnberg Medical School

University of Freiburg

Investigators


Principal Investigator:	Hagen Huttner, MD	Neurology Department, University of Erlangen-Nuremberg
Principal Investigator:	Dimitre Staykov, MD	Neurology Department, University of Erlangen-Nuremberg
Study Chair:	Jürgen Bardutzky, MD	University of Freiburg

More Information


Responsible Party:	Dimitre Staykov, Priv.-Doz. Dr. med., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:	NCT01041950 History of Changes
Other Study ID Numbers:	LUCAS-IVH
Study First Received:	January 4, 2010
Last Updated:	June 23, 2016
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg Medical School:


intracerebral hemorrhage intraventricular hemorrhage hydrocephalus Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus

Additional relevant MeSH terms:


Hemorrhage Cerebral Hemorrhage Hydrocephalus Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders	Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2016

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