Optimal Prophylactic Method of Venous Thromboembolism (VTE)

NCT ID: NCT01448746

Last Updated: 2017-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

682 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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intermittent pneumatic compression

another arm include intermittent pneumatic compression plus low molecular weight heparin

Group Type EXPERIMENTAL

low molecular weight heparin

Intervention Type DRUG

40mg 12 hours before surgery and 12 hours later surgery

Interventions

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low molecular weight heparin

40mg 12 hours before surgery and 12 hours later surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Kyo Young Song

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyo Young Song, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 35089599 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34878173 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34622445 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30027281 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25012265 (View on PubMed)

Other Identifiers

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CUMC-GC2011

Identifier Type: -

Identifier Source: org_study_id

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