Study of Admission Versus Discharge After Transient Ische... | NCT00304798

Studies
Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)

NCT00304798

Sponsor

University of California, San Diego

Status

Withdrawn

Last Update Posted

Feb 4, 2015Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Transient Ischemic Attack (TIA)
Stroke

Interventions

Hospital admission

Countries

United States

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

Mar 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Mar 16, 2006

First Submission Date that Met QC Criteria

Mar 16, 2006

First Posted Date

Mar 20, 2006Estimated

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

Feb 3, 2015

Last Update Posted Date

Feb 4, 2015Estimated

Description Module

Brief Summary

Evaluate for difference in outcome between hospital admission versus discharge after recent TIA, and evaluate feasibility of a larger study.

Detailed Description

20 patients will be randomized within 24 hours of a TIA to be admitted to the hospital or discharged to home, and the investigator will compare outcomes, cost, and evaluate the feasibility of a larger study.

Design Module

Study Type

Interventional

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Admission	Experimental	Admission	Behavioral: Hospital admission
Discharge	No Intervention	Discharge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hospital admission	Behavioral		Admission

Measure	Description	Time Frame
modified Rankin Scale at one year.		1 year

Measure	Description	Time Frame
Stroke and TIA incidence at one year		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 and older.
Clinical diagnosis of TIA within 24 hours of consent.

Exclusion Criteria:

Crescendo TIAs, defined as multiple within 24 hours of presentation.
Posterior circulation TIAs diagnosed clinically by a member of the Stroke Team.
High grade carotid stenosis.
Any compelling medical reason they should or should not be admitted or discharged (for example decompensated congestive heart failure, unstable angina, new EKG changes, pneumonia, sepsis). Patients will only be enrolled if the only consideration for admission is the TIA, and they otherwise meet appropriate standard of care criteria for discharge to home.
Patients will be excluded if no one can be with them for the next 12 hours to ensure a rapid call to 911 should problems arise, specifically stroke.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matt B Jensen, MD	UCSD Stroke Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSD		San Diego	California	92103	United States

Condition Browse Module

MeSH Terms

ID	Term
D002546	Ischemic Attack, Transient
D020521	Stroke

Ancestor Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided