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Optimal Prophylactic Method of Venous Thromboembolism (VTE)

This study is currently recruiting participants.
Verified October 2011 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Kyo Young Song, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01448746
First received: October 5, 2011
Last updated: October 6, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
 Drug: low molecular weight heparin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • incidence of VTE [ Time Frame: up to 30 days after operation ] [ Designated as safety issue: No ]
    The incidence of VTE between mechanical method only group and mechnical plus LMWH group.


Secondary Outcome Measures:
  • Adverse event [ Time Frame: up to 30 days after operation ] [ Designated as safety issue: Yes ]
    The adverse event such as bleeding will also be compared.


Estimated Enrollment: 682
Study Start Date: October 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intermittent pneumatic compression
another arm include intermittent pneumatic compression plus low molecular weight heparin
 Drug: low molecular weight heparin
40mg 12 hours before surgery and 12 hours later surgery

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448746

Contacts
Contact: Kyo Young Song, M.D. +82222586106 skys9615@gmail.com

Locations
Korea, Republic of
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137701
Contact: Kyo Young Song, M.D.     +82222586106     skys9615@gmail.com    
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Kyo Young Song, M.D. The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Kyo Young Song, Associate Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01448746     History of Changes
Other Study ID Numbers: CUMC-GC2011
Study First Received: October 5, 2011
Last Updated: October 6, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
gastric cancer
VTE
incidence

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Heparin
Heparin, Low-Molecular-Weight
 Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013