Optimal Prophylactic Method of Venous Thromboembolism (VTE)

The Catholic University of Korea

Status and phase: Unknown; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: low molecular weight heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01448746

CUMC-GC2011

Details and patient eligibility

About

This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.

Full description

Venous thromboembolism (VTE) is common and often fatal complication in patients with cancer.

Gastric cancer is the most frequent cancer in Korea.

The incidence of VTE would be increased in patients with gastric cancer, especially associated surgery.

However, the incidence and optimal prophylactic method associated with cancer surgery are not well studied in Asian patients.

Most Korean surgeon concerns regarding the increased postoperative bleeding associated with low molecular weight heparin(LMWH)prophylaxis.

The incidence and adverse event will be examined to define the optimal prophylactic method of VTE in surgical patients with gastric cancer.

Enrollment: 682 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed as gastric cancer
• Elective and curative under general anesthesia
• ECOG score 0-2
• ASA score 3 or less than 3
• Informed consents

Exclusion criteria

• 2nd primary cancer
• VTE history within one year
• Anticoagulation history
• Allergic to heparin
• Pregnancy or expected pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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682 participants in 1 patient group

intermittent pneumatic compression

Experimental group

Description:

another arm include intermittent pneumatic compression plus low molecular weight heparin

Treatment:

Drug: low molecular weight heparin