Investigation of Platelet Function and Aspirin Resistance... | NCT01045785

Studies
Investigation of Platelet Function and Aspirin Resistance in Chronic Dialysis Patient

NCT01045785

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jan 11, 2010Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

End Stage Renal Disease

Interventions

Not provided

Countries

Taiwan

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jun 2010Estimated

Completion Date

Jul 2010Estimated

First Submitted Date

Jan 8, 2010

First Submission Date that Met QC Criteria

Jan 8, 2010

First Posted Date

Jan 11, 2010Estimated

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 8, 2010

Last Update Posted Date

Jan 11, 2010Estimated

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 purpose of this study is to determine whether aspirin resistance has impact on cardiovascular event in dialysis patient.

Detailed Description

Dialysis patient inevitably suffered from uremic bleeding although improvement of dialysis care in the past decades. Physicians used to check bleeding time as a surrogate marker for uremic bleeding. However, bleeding time isn't accurate and as well known, is poorly correlated with clinical bleeding such as surgical bleeding. Platelet function assay (PFA) is a newly developed method to measure platelet aggregation in vitro and is validated in many sorts of platelet disorders. Recently, PFA was also used to evaluate aspirin responsiveness in patients who had taken aspirin. Our study is aim to investigate uremic thrombocytopathy via PFA of dialysis patient in Taiwan. Furthermore, we will study aspirin resistance in dialysis patient.

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aspirin responsive		PFA Col/EPI normal
aspirin resistance		PFA Col/epi showed resistance

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cardiovascular event, bleeding event,and thrombosis		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

dialysis >3 months
Hb>10 g/dl & Plt > 10000

Exclusion Criteria:

using medication which interfere PFA except aspirin
terminal disease such as malignancy
active vasculitis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Dialysis patients which follow-up at least monthly at National Taiwan University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jenqwen Huang, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei	Taiwan	100	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17325638	Background	Bilgin AU, Karadogan I, Artac M, Kizilors A, Bligin R, Undar L. Hemodialysis shortens long in vitro closure times as measured by the PFA-100. Med Sci Monit. 2007 Mar;13(3):CR141-5.

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases