NCT00685958

Brief Summary

The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

July 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
Last Updated

October 2, 2009

Status Verified

October 1, 2009

Enrollment Period

8 months

First QC Date

May 26, 2008

Last Update Submit

October 1, 2009

Conditions

Hip Fractures

Keywords

Blood thinnerenoxaparinhip fracture surgerybleedingthromboembolism

Outcome Measures

Primary Outcomes (1)

  • bleeding events

    28 days

Secondary Outcomes (1)

  • incidence of venous thromboembolism

    28 days

Interventions

enoxaparin (XRP4563)DRUG

14 days of treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • femoral neck inside or outside fracture

You may not qualify if:

  • any major surgery on lower limbs within 3 months
  • clinical signs of deep vein thrombosis
  • use of non-steroidal anti-inflammatory drugs
  • severe hepatic disease or renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi- Aventis Administrative Office

Tokyo, Japan

Location

MeSH Terms

Conditions

Hip FracturesHemorrhageThromboembolism

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 26, 2008

First Posted

May 29, 2008

Study Start

July 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

October 2, 2009

Record last verified: 2009-10

Locations

JP(1)