NCT01041950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
2.3 years until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

January 4, 2010

Last Update Submit

October 25, 2016

Conditions

Intracerebral HemorrhageObstructive Hydrocephalus

Keywords

intracerebral hemorrhageintraventricular hemorrhagehydrocephalusIntracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Safety aspects

    during hospital stay

  • mortality and outcome

    3 and 6 months

Study Arms (2)

Lumbar drainage

EXPERIMENTAL
Procedure: Lumbar drainage

Control

NO INTERVENTION

Interventions

Lumbar drainagePROCEDURE

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

Lumbar drainage

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology Department, University of Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

Related Publications (1)

  • Staykov D, Kuramatsu JB, Bardutzky J, Volbers B, Gerner ST, Kloska SP, Doerfler A, Schwab S, Huttner HB. Efficacy and safety of combined intraventricular fibrinolysis with lumbar drainage for prevention of permanent shunt dependency after intracerebral hemorrhage with severe ventricular involvement: A randomized trial and individual patient data meta-analysis. Ann Neurol. 2017 Jan;81(1):93-103. doi: 10.1002/ana.24834.

    PMID: 27888608DERIVED

MeSH Terms

Conditions

Cerebral HemorrhageHydrocephalus

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hagen Huttner, MD

    Neurology Department, University of Erlangen-Nuremberg

    PRINCIPAL INVESTIGATOR

  • Dimitre Staykov, MD

    Neurology Department, University of Erlangen-Nuremberg

    PRINCIPAL INVESTIGATOR

  • Jürgen Bardutzky, MD

    University of Freiburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. Dr. med.

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

May 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

DE(1)