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Optimal Prophylactic Method of Venous Thromboembolism (VTE)

Primary Purpose

Venous Thromboembolism

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
low molecular weight heparin
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring gastric cancer, VTE, incidence

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intermittent pneumatic compression

Arm Description

another arm include intermittent pneumatic compression plus low molecular weight heparin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse event
The adverse event such as bleeding will also be compared.

Full Information

First Posted
October 5, 2011
Last Updated
February 3, 2017
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01448746
Brief Title
Optimal Prophylactic Method of Venous Thromboembolism (VTE)
Official Title
Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
gastric cancer, VTE, incidence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
682 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intermittent pneumatic compression
Arm Type
Experimental
Arm Description
another arm include intermittent pneumatic compression plus low molecular weight heparin
Intervention Type
Drug
Intervention Name(s)
low molecular weight heparin
Intervention Description
40mg 12 hours before surgery and 12 hours later surgery
Primary Outcome Measure Information:
Title
incidence of VTE
Description
The incidence of VTE between mechanical method only group and mechnical plus LMWH group.
Time Frame
up to 30 days after operation
Secondary Outcome Measure Information:
Title
Adverse event
Description
The adverse event such as bleeding will also be compared.
Time Frame
up to 30 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyo Young Song, M.D.
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
35089599
Citation
Kakkos S, Kirkilesis G, Caprini JA, Geroulakos G, Nicolaides A, Stansby G, Reddy DJ. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev. 2022 Jan 28;1(1):CD005258. doi: 10.1002/14651858.CD005258.pub4.
Results Reference
derived
PubMed Identifier
34878173
Citation
Kahale LA, Matar CF, Hakoum MB, Tsolakian IG, Yosuico VE, Terrenato I, Sperati F, Barba M, Schunemann H, Akl EA. Anticoagulation for the initial treatment of venous thromboembolism in people with cancer. Cochrane Database Syst Rev. 2021 Dec 8;12(12):CD006649. doi: 10.1002/14651858.CD006649.pub8.
Results Reference
derived
PubMed Identifier
34622445
Citation
Kahale LA, Matar CF, Tsolakian I, Hakoum MB, Barba M, Yosuico VE, Terrenato I, Sperati F, Schunemann H, Akl EA. Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD006466. doi: 10.1002/14651858.CD006466.pub7.
Results Reference
derived
PubMed Identifier
30027281
Citation
Jung YJ, Seo HS, Park CH, Jeon HM, Kim JI, Yim HW, Song KY. Venous Thromboembolism Incidence and Prophylaxis Use After Gastrectomy Among Korean Patients With Gastric Adenocarcinoma: The PROTECTOR Randomized Clinical Trial. JAMA Surg. 2018 Oct 1;153(10):939-946. doi: 10.1001/jamasurg.2018.2081.
Results Reference
derived
PubMed Identifier
25012265
Citation
Song KY, Yoo HM, Kim EY, Kim JI, Yim HW, Jeon HM, Park CH. Optimal prophylactic method of venous thromboembolism for gastrectomy in Korean patients: an interim analysis of prospective randomized trial. Ann Surg Oncol. 2014 Dec;21(13):4232-8. doi: 10.1245/s10434-014-3893-1. Epub 2014 Jul 11.
Results Reference
derived

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Optimal Prophylactic Method of Venous Thromboembolism (VTE)

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