Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Effectiveness and Safety of Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02935530

Enrollment

315

Registered

2016-10-17

Start date

2016-01-31

Completion date

2017-10-31

Last updated

2019-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Neoplasms, Venous Thromboembolism, Low Molecular Weight Heparin, Argatroban

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.

Interventions

DRUGs-LMWH

2125KU, subcutaneous injection of 5-10 days

DRUGLMWH

4250KU, subcutaneous injection of 5-10 days

DRUGArgatroban

20mg, injection for 5-10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
VTE rate	30-days from the date of operation

Secondary

Measure	Time frame
Bleeding rate	30-days from the date of operation
Infection rate	30-days from the date of operation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026