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Optimal Prophylactic Method of Venous Thromboembolism (VTE)

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ClinicalTrials.gov Identifier: NCT01448746
Recruitment Status : Active, not recruiting
First Posted : October 7, 2011
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Kyo Young Song, 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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: low molecular weight heparin Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 682 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Study Start Date : October 2011
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. incidence of VTE [ Time Frame: up to 30 days after operation ]
    The incidence of VTE between mechanical method only group and mechnical plus LMWH group.


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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448746


Locations
Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137701
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Kyo Young Song, M.D. The Catholic University of Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Kyo Young Song, The Catholic University of Korea:
gastric cancer
VTE
incidence

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