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Optimal Prophylactic Method of Venous Thromboembolism (VTE)

Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01448746
Enrollment
682
Registered
2011-10-07
Start date
2011-10-31
Completion date
2017-08-31
Last updated
2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

gastric cancer, VTE, incidence

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.

Interventions

DRUGlow molecular weight heparin

40mg 12 hours before surgery and 12 hours later surgery

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of VTEup to 30 days after operationThe incidence of VTE between mechanical method only group and mechnical plus LMWH group.

Secondary

MeasureTime frameDescription
Adverse eventup to 30 days after operationThe adverse event such as bleeding will also be compared.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026