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Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients


Phase 3
20 Years
75 Years
Open (Enrolling)
Both
Venous Thromboembolism

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Trial Information

Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

incidence of VTE

Outcome Description:

The incidence of VTE between mechanical method only group and mechnical plus LMWH group.

Outcome Time Frame:

up to 30 days after operation

Safety Issue:

No

Principal Investigator

Kyo Young Song, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Catholic University of Korea

Authority:

Korea: Institutional Review Board

Study ID:

CUMC-GC2011

NCT ID:

NCT01448746

Start Date:

October 2011

Completion Date:

September 2014

Related Keywords:

  • Venous Thromboembolism
  • gastric cancer
  • VTE
  • incidence
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis

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