Gynecologic NeoplasmsPhase 3NCT02935530
Thromboprophylaxis After Surgery for Gynecologic Malignancy in China
A Phase 3 study testing s-LMWH, LMWH and Argatroban in people with Gynecologic Neoplasms and Venous Thromboembolism, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Venous thromboembolism (VTE) is an important cause of post-operative morbidity and mortality in women undergoing surgery for gynecologic malignancies. Although the benefit of thromboprophylaxis in reduction of post-operative VTE events after surgery for gynecologic cancers has been well documented around the world… Read more about this study
- Who is it for?
- Ages 16 to 70 years, women only
- Conditions the study is for
- Gynecologic Neoplasms, Venous Thromboembolism, Low Molecular Weight Heparin
- What is being tested?
- s-LMWH, LMWH and Argatroban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Oct 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 16 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of ovarian cancer, cervix cancer or endometrial cancer;
- Age ≤ 70 years; female, Chinese women;
- Initial treatment is surgery;
- Laboratory tests: WBC ≥ 4×10(9)/L, NEU ≥ 2×10(9)/L, PLT ≥ 100×10(9)/L, serum bilirubin ≤ 1.5 times the upper limit of normal, transaminase ≤ 1.5 times the upper limit of normal, BUN, Cr ≤ normal
- No prior pharmacologic prophylaxis;
- Provide written informed consent.
Who cannot join
- PLT ≤ 75×10(9)/L
- Vascular injury
- History of thrombosis
- Liver and kidney dysfunction
- Concurrently participating in other clinical trials
- Unable or unwilling to sign informed consents;
- Unable or unwilling to abide by protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Thromboprophylaxis After Surgery for Gynecologic Malignancy in China
Venous thromboembolism (VTE) is an important cause of post-operative morbidity and mortality in women undergoing surgery for gynecologic malignancies. Although the benefit of thromboprophylaxis in reduction of post-operative VTE events after surgery for gynecologic cancers has been well documented around the world, the evidence for Chinese women is rare. The investigators designed this prospective and randomized study to assess the benefit of pharmacologic prophylaxis for patients received surgical treatment for gynecologic malignancies in China.
- Being tested
- s-LMWH, LMWH, Argatroban
- Medical subject headings
- Genital Neoplasms, Female, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
s-LMWHDrug
2125KU, subcutaneous injection of 5-10 days
LMWHDrug
4250KU, subcutaneous injection of 5-10 days
ArgatrobanDrug
20mg, injection for 5-10 days
| Study group | Role | What they receive |
|---|---|---|
| s-LMWH | Experimental | 2125 I.U. subcutaneous injection for 5-10 days Receives: Drug: s-LMWH |
| LMWH | Active comparator | 4250 I.U. subcutaneous injection for 5-10 days Receives: Drug: LMWH |
| Argatroban | Experimental | 20mg, injection for 5-10 days Receives: Drug: Argatroban |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE rate
Measured: 30-days from the date of operation
Secondary outcomes (2)
Bleeding rate
Measured: 30-days from the date of operation
Infection rate
Measured: 30-days from the date of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Ding Ma, M.D., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935530
- Sponsor's protocol ID
- VTE-01
- Status last verified
- May 2019
- First submitted
- 14 Oct 2016
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Thromboprophylaxis After Surgery for Gynecologic Malignancy in China
- ClinicalTrials.gov ID
- NCT02935530
- Acronym / sponsor ID
- VTE-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 17 Oct 2016 (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.
Venous thromboembolism (VTE) is an important cause of post-operative morbidity and mortality in women undergoing surgery for gynecologic malignancies. Although the benefit of thromboprophylaxis in reduction of post-operative VTE events after surgery for gynecologic cancers has been well documented around the world, the evidence for Chinese women is rare. The investigators designed this prospective and randomized study to assess the benefit of pharmacologic prophylaxis for patients received surgical treatment for gynecologic malignancies in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| s-LMWH | Experimental | Drug: s-LMWH2125 I.U. subcutaneous injection for 5-10 days |
| LMWH | Active comparator | Drug: LMWH4250 I.U. subcutaneous injection for 5-10 days |
| Argatroban | Experimental | Drug: Argatroban20mg, injection for 5-10 days |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of ovarian cancer, cervix cancer or endometrial cancer;
- Age ≤ 70 years; female, Chinese women;
- Initial treatment is surgery;
- Laboratory tests: WBC ≥ 4×10(9)/L, NEU ≥ 2×10(9)/L, PLT ≥ 100×10(9)/L, serum bilirubin ≤ 1.5 times the upper limit of normal, transaminase ≤ 1.5 times the upper limit of normal, BUN, Cr ≤ normal
- No prior pharmacologic prophylaxis;
Key exclusion criteria (7 listed)
- PLT ≤ 75×10(9)/L
- Vascular injury
- History of thrombosis
- Liver and kidney dysfunction
- Concurrently participating in other clinical trials
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 |
|---|---|---|
| s-LMWH2125KU, subcutaneous injection of 5-10 days | Drug | s-LMWH |
| LMWH4250KU, subcutaneous injection of 5-10 days | Drug | LMWH |
| Argatroban20mg, injection for 5-10 days | Drug | Argatroban |
Primary outcome
VTE rate
Time frame: 30-days from the date of operation
2 secondary outcomes
Bleeding rate
Time frame: 30-days from the date of operation
Infection rate
Time frame: 30-days from the date of operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: No
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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.
Ding Ma, M.D. study chair
Tongji Hospital
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 s-LMWH, LMWH and Argatroban in people with Gynecologic Neoplasms and Venous Thromboembolism, run by Huazhong University of Science and Technology at 1 site in China.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 14 May 2019. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VTE rate (time frame: 30-days from the date of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2019.