Long Term Outcome After Hemorrhagic Stroke Surgery | NCT01409252

Studies
Long Term Outcome After Hemorrhagic Stroke Surgery

NCT01409252

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Jan 14, 2013Estimated

Enrollment

191Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 3, 2011

First Submission Date that Met QC Criteria

Aug 3, 2011

First Posted Date

Aug 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2013

Last Update Posted Date

Jan 14, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

George KC Wong, Professor (Clinical), Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators retrospectively reviewed all patients with neurosurgical operations for hemorrhagic stroke (intracerebral hemorrhage) between 1999 and 2008. Research assistant then telephoned the survivors for neurological and cognitive status.

Detailed Description

Death at one year for intracerebral hemorrhage varies by location, with 42% for cerebellar in one series. Of patients who had intracerebral hemorrhage in the United States during 2002, only 20% are expected to be functionally independently at 6 months. Although case series established the value of selected timely hematoma evacuation, long term clinical outcome, especially on cognition, is not well described in the literature. With these in mind, we carried out this study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

191Actual

Label	Type	Description	Intervention Names
Hemorrhagic stroke patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modified Rankin Scale		Cross-sectional at 2-12 years after ictus

Secondary Outcomes

Measure	Description	Time Frame
Barthel Index	Basic Activity of Daily Living	Cross-sectional at 2-12 years post-ictus
Telephone Interview of Cognitive Status		Cross-sectional at 2-12 years post-ictus

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All hemorrhagic stroke patients with neurosurgical operations performed between 1999 and 2008.

Exclusion Criteria:

Spontaneous subarachnoid hemorrhage as the dominant etiology
uncommunicable patients
nonsurvivors

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Spontaneous intracerebral hemorrhage with neurosurgical operations

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Wong, MD(CUHK) FRCSEd(SN)	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, The Chinese University of Hong Kong		Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D002543	Cerebral Hemorrhage

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided