Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gynecologic Neoplasms Venous Thromboembolism Low Molecular Weight Heparin Argatroban

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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s-LMWH

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

Group Type EXPERIMENTAL

s-LMWH

Intervention Type DRUG

2125KU, subcutaneous injection of 5-10 days

LMWH

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

Group Type ACTIVE_COMPARATOR

LMWH

Intervention Type DRUG

4250KU, subcutaneous injection of 5-10 days

Argatroban

20mg, injection for 5-10 days

Group Type EXPERIMENTAL

Argatroban

Intervention Type DRUG

20mg, injection for 5-10 days

Interventions

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s-LMWH

2125KU, subcutaneous injection of 5-10 days

Intervention Type DRUG

LMWH

4250KU, subcutaneous injection of 5-10 days

Intervention Type DRUG

Argatroban

20mg, injection for 5-10 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No