Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Phase 3

Completed

• Conditions: Argatroban; Gynecologic Neoplasms; Low Molecular Weight Heparin; Venous Thromboembolism
• Interventions: Drug: LMWH; Drug: s-LMWH; Drug: Argatroban

• Registration Number: NCT02935530
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-17
• Primary Completion: 2017-08
• Study Completion: 2017-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-12
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 315

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMWH	LMWH	4250 I.U. subcutaneous injection for 5-10 days
s-LMWH	s-LMWH	2125 I.U. subcutaneous injection for 5-10 days
Argatroban	Argatroban	20mg, injection for 5-10 days

Primary Outcome Measures

Name	Time	Method
VTE rate	30-days from the date of operation

Secondary Outcome Measures

Name	Time	Method
Infection rate	30-days from the date of operation
Bleeding rate	30-days from the date of operation

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China