Optimal Prophylactic Method of Venous Thromboembolism (VTE) | NCT01448746

Studies
Optimal Prophylactic Method of Venous Thromboembolism (VTE)

NCT01448746

Sponsor

The Catholic University of Korea

Status

Unknown status

Last Update Posted

Feb 7, 2017Estimated

Enrollment

682Actual

Phase

Phase 3

Conditions

Venous Thromboembolism

Interventions

low molecular weight heparin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jan 2016Actual

Completion Date

Aug 2017Estimated

First Submitted Date

Oct 5, 2011

First Submission Date that Met QC Criteria

Oct 6, 2011

First Posted Date

Oct 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2017

Last Update Posted Date

Feb 7, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kyo Young Song, Associate Professor, The Catholic University of KoreaPrincipal Investigator

Lead Sponsor

The Catholic University of KoreaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

682Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intermittent pneumatic compression	Experimental	another arm include intermittent pneumatic compression plus low molecular weight heparin	Drug: low molecular weight heparin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low molecular weight heparin	Drug	40mg 12 hours before surgery and 12 hours later surgery	intermittent pneumatic compression

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of VTE	The incidence of VTE between mechanical method only group and mechnical plus LMWH group.	up to 30 days after operation

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyo Young Song, M.D.	The Catholic University of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St. Mary's Hospital		Seoul		137701	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35089599	Derived	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.
34878173	Derived

ID	Term
D054556	Venous Thromboembolism
D013274	Stomach Neoplasms

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates