Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02935530

Collaborator

(none)

315

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Neoplasms Venous Thromboembolism Low Molecular Weight Heparin Argatroban	Drug: s-LMWH Drug: LMWH Drug: Argatroban	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

315 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: s-LMWH 2125 I.U. subcutaneous injection for 5-10 days	Drug: s-LMWH 2125KU, subcutaneous injection of 5-10 days
Active Comparator: LMWH 4250 I.U. subcutaneous injection for 5-10 days	Drug: LMWH 4250KU, subcutaneous injection of 5-10 days
Experimental: Argatroban 20mg, injection for 5-10 days	Drug: Argatroban 20mg, injection for 5-10 days

Arm

Intervention/Treatment

Experimental: s-LMWH

2125 I.U. subcutaneous injection for 5-10 days

Drug: s-LMWH

2125KU, subcutaneous injection of 5-10 days

Active Comparator: LMWH

4250 I.U. subcutaneous injection for 5-10 days

Drug: LMWH

4250KU, subcutaneous injection of 5-10 days

Experimental: Argatroban

20mg, injection for 5-10 days

Drug: Argatroban

20mg, injection for 5-10 days

Outcome Measures

Primary Outcome Measures

VTE rate [30-days from the date of operation]

Secondary Outcome Measures

Bleeding rate [30-days from the date of operation]
Infection rate [30-days from the date of operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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.