Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery

Sanofi

Status and phase: Completed; Phase 3

Conditions: Abdominal Neoplasms

Treatments: Drug: enoxaparin; Other: Physical prophylaxis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00723216

EFC10094

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

151 participants in 2 patient groups

1

Active Comparator group

Description:

Enoxaparin

Treatment:

Drug: enoxaparin

2

Other group

Description:

Intermittent Pneumatic Compression (IPC)

Treatment:

Other: Physical prophylaxis