NCT00723216

Brief Summary

The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2007

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

March 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
Last Updated

April 5, 2010

Status Verified

April 1, 2010

Enrollment Period

9 months

First QC Date

July 24, 2008

Last Update Submit

April 2, 2010

Conditions

Abdominal Neoplasms

Keywords

Preventionvenous thromboembolismcurative surgery

Outcome Measures

Primary Outcomes (1)

  • Venous thromboembolism incidence

    28 days

Secondary Outcomes (1)

  • Incidence of deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism incidence except patients with thrombus only in muscle veins, and incidence of proximal vein thrombosis

    28 days

Study Arms (2)

1

ACTIVE COMPARATOR

Enoxaparin

Drug: enoxaparin

2

OTHER

Intermittent Pneumatic Compression (IPC)

Other: Physical prophylaxis

Interventions

enoxaparinDRUG

20 mg twice a day

1
Physical prophylaxisOTHER
2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more.

You may not qualify if:

  • surgery under laparoscope and other endoscopic operations
  • clinical signs of deep vein thrombosis
  • use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration
  • severe hepatic disease or renal disease
  • women of childbearing potential, pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

MeSH Terms

Conditions

Abdominal NeoplasmsVenous Thromboembolism

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • International Clinical Development, Clinical Study Director

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 5, 2010

Record last verified: 2010-04

Locations

JP(1)