Optimal Prophylactic Method of Venous Thromboembolism (VTE)

Phase 3

• Conditions: Venous Thromboembolism
• Interventions: Drug: low molecular weight heparin

• Registration Number: NCT01448746
• Lead Sponsor: The Catholic University of Korea

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Primary Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 682

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent pneumatic compression	low molecular weight heparin	another arm include intermittent pneumatic compression plus low molecular weight heparin

Primary Outcome Measures

Name	Time	Method
incidence of VTE	up to 30 days after operation	The incidence of VTE between mechanical method only group and mechnical plus LMWH group.

Secondary Outcome Measures

Name	Time	Method
Adverse event	up to 30 days after operation	The adverse event such as bleeding will also be compared.

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of