Venous ThromboembolismPhase 3NCT01448746
Optimal Prophylactic Method of Venous Thromboembolism (VTE)
A Phase 3 study testing low molecular weight heparin in people with Venous Thromboembolism, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- low molecular weight heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as gastric cancer
- Elective and curative under general anesthesia
- ECOG score 0-2
- ASA score 3 or less than 3
- Informed consents
Who cannot join
- 2nd primary cancer
- VTE history within one year
- Anticoagulation history
- Allergic to heparin
- Pregnancy or expected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Being tested
- low molecular weight heparin
- Keywords
- gastric cancer, VTE, incidence
- Medical subject headings
- Venous Thromboembolism, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low molecular weight heparinDrug
40mg 12 hours before surgery and 12 hours later surgery
| Study group | Role | What they receive |
|---|---|---|
| intermittent pneumatic compression | Experimental | another arm include intermittent pneumatic compression plus low molecular weight heparin Receives: Drug: low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of VTE
The incidence of VTE between mechanical method only group and mechnical plus LMWH group.
Measured: up to 30 days after operation
Secondary outcomes (1)
Adverse event
The adverse event such as bleeding will also be compared.
Measured: up to 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2016
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyo Young Song, The Catholic University of Korea
- Investigators
- Kyo Young Song, M.D., Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448746
- Sponsor's protocol ID
- CUMC-GC2011
- Status last verified
- Feb 2017
- First submitted
- 5 Oct 2011
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35089599Kahale 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.
PubMed 34878173Kahale 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.
PubMed 34622445Jung 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.
PubMed 30027281Song 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.
PubMed 25012265
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
- ClinicalTrials.gov ID
- NCT01448746
- Acronym / sponsor ID
- CUMC-GC2011
- Conditions
- Venous Thromboembolism
- Keywords
- gastric cancer, VTE, incidence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 682 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intermittent pneumatic compression | Experimental | Drug: low molecular weight heparinanother arm include intermittent pneumatic compression plus low molecular weight heparin |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed as gastric cancer
- Elective and curative under general anesthesia
- ECOG score 0-2
- ASA score 3 or less than 3
- Informed consents
Key exclusion criteria (5 listed)
- 2nd primary cancer
- VTE history within one year
- Anticoagulation history
- Allergic to heparin
- Pregnancy or expected pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low molecular weight heparin40mg 12 hours before surgery and 12 hours later surgery | Drug | intermittent pneumatic compression |
Primary outcome
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.
1 secondary outcome
Adverse event
Time frame: up to 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Derived from this study: PubMed 35089599Kakkos 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.
- Derived from this study: PubMed 34878173Kahale 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.
- Derived from this study: PubMed 34622445Kahale 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.
- Derived from this study: PubMed 30027281Jung 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.
- Derived from this study: PubMed 25012265Song 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyo Young Song, M.D. principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing low molecular weight heparin in people with Venous Thromboembolism, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of VTE (time frame: up to 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448746, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.