Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

May 12, 2019 updated by: Ding Ma, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VTE rate
Time Frame: 30-days from the date of operation
30-days from the date of operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding rate
Time Frame: 30-days from the date of operation
30-days from the date of operation
Infection rate
Time Frame: 30-days from the date of operation
30-days from the date of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Investigators

  • Study Chair: Ding Ma, M.D., Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 12, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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