Optimal Prophylactic Method of Venous Thromboembolism (VTE)

Venous Thromboembolism Clinical Trial

Official title:

Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01448746
• Other study ID #: CUMC-GC2011
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 5, 2011
• Last updated: February 3, 2017
• Start date: October 2011
• Est. completion date: August 2017

Study information

• Verified date: February 2017
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 682
• Est. completion date: August 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• low molecular weight heparin
40mg 12 hours before surgery and 12 hours later surgery

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of VTE	The incidence of VTE between mechanical method only group and mechnical plus LMWH group.	up to 30 days after operation
Secondary	Adverse event	The adverse event such as bleeding will also be compared.	up to 30 days after operation