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Completed

NCT Number: NCT02935530

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.

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Key information

Conditions

Gynecologic Neoplasms Argatroban Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Low Molecular Weight Heparin Neoplasms Neoplasms by Site Thromboembolism Urogenital Diseases Urogenital Neoplasms Vascular Diseases Venous Thromboembolism

Age range

16 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

s-LMWH

Drug

2125KU, subcutaneous injection of 5-10 days

LMWH

Drug

4250KU, subcutaneous injection of 5-10 days

Argatroban

Drug

20mg, injection for 5-10 days

Primary outcomes

  1. VTE rate

    Time frame: 30-days from the date of operation

Secondary outcomes

  1. Bleeding rate

    Time frame: 30-days from the date of operation

  2. Infection rate

    Time frame: 30-days from the date of operation

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2016
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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