Thromboprophylaxis After Surgery for Gynecologic Malignancy in China
Effectiveness and Safety of Thromboprophylaxis After Surgery for Gynecologic Malignancy in China
1 other identifier
interventional
315
1 country
1
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 14, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMay 14, 2019
May 1, 2019
1.6 years
October 14, 2016
May 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
VTE rate
30-days from the date of operation
Secondary Outcomes (2)
Bleeding rate
30-days from the date of operation
Infection rate
30-days from the date of operation
Study Arms (3)
s-LMWH
EXPERIMENTAL2125 I.U. subcutaneous injection for 5-10 days
LMWH
ACTIVE COMPARATOR4250 I.U. subcutaneous injection for 5-10 days
Argatroban
EXPERIMENTAL20mg, injection for 5-10 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 430000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ding Ma, M.D.
Tongji Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the department of Obstetrics and Gynecology, Tongji Hospital
Study Record Dates
First Submitted
October 14, 2016
First Posted
October 17, 2016
Study Start
January 1, 2016
Primary Completion
August 1, 2017
Study Completion
October 1, 2017
Last Updated
May 14, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share