The Effect of Reduced Dose of Enoxaparin on the Outcomes... | NCT00354796

Studies
The Effect of Reduced Dose of Enoxaparin on the Outcomes of Treatment With Enoxaparin

NCT00354796

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jul 6, 2011Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome
Venous Thromboembolism
Atrial Fibrillation
Hypercoagulability

Interventions

Not provided

Countries

Israel

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Oct 2015Estimated

First Submitted Date

Jul 19, 2006

First Submission Date that Met QC Criteria

Jul 19, 2006

First Posted Date

Jul 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

Jul 3, 2011

Last Update Posted Date

Jul 6, 2011Estimated

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

We hypothesize that reduced dose of enoxaparin in elderly patients will result in reduced proportion of patients with therapeutic anti Xa activity and reduced clinical efficacy.

Detailed Description

Patients treated with enoxaparin will be followed, sociodemographic , clinical and laboratory data will be collected. Clinical efficacy as well as adverse events will be monitored.

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

500Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

treatment with enoxaparin

Exclusion Criteria:

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

patients admitted to tertiary hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mordechai Muszkat, MD	Contact	00-972-2-6776449		muszkatm@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Mordechai Muszkat, MD	Hadassah University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D054556	Venous Thromboembolism
D001281	Atrial Fibrillation
D019851	Thrombophilia
D006470	Hemorrhage

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided