Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935530
• Other study ID #: VTE-01
• Status: Completed
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: October 2017

Study information

• Verified date: May 2019
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Argatroban
• Genital Neoplasms, Female
• Gynecologic Neoplasms
• Low Molecular Weight Heparin
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• s-LMWH
2125KU, subcutaneous injection of 5-10 days
• LMWH
4250KU, subcutaneous injection of 5-10 days
• Argatroban
20mg, injection for 5-10 days

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE rate		30-days from the date of operation
Secondary	Bleeding rate		30-days from the date of operation
Secondary	Infection rate		30-days from the date of operation