Clinical trial NCT01448746: Optimal Prophylactic Method of Venous Thromboembolism (VTE)
Official title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: gastric cancer
VTE
incidence
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 682
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: incidence of VTE
timeFrame: up to 30 days after operation
Secondary outcomes:
measure: Adverse event
timeFrame: up to 30 days after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Kyo Young Song, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.