Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Huazhong University of Science and Technology

Status and phase: Completed; Phase 3

Conditions: Argatroban; Venous Thromboembolism; Low Molecular Weight Heparin; Gynecologic Neoplasms

Treatments: Drug: s-LMWH; Drug: LMWH; Drug: Argatroban

Study type: Interventional

Funder types: Other

Identifiers

NCT02935530

VTE-01

Details and patient eligibility

About

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.

Enrollment: 315 patients

Sex: Female

Ages: 16 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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315 participants in 3 patient groups

s-LMWH

Experimental group

Description:

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

Treatment:

Drug: s-LMWH

LMWH

Active Comparator group

Description:

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

Treatment:

Drug: LMWH

Argatroban

Experimental group

Description:

20mg, injection for 5-10 days

Treatment:

Drug: Argatroban