Optimal Prophylactic Method of Venous Thromboembolism (VTE)

February 3, 2017 updated by: Kyo Young Song, The Catholic University of Korea

Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

682

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 30 days after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: up to 30 days after operation
The adverse event such as bleeding will also be compared.
up to 30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Kyo Young Song, M.D., The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

October 5, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUMC-GC2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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