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Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Primary Purpose

Gynecologic Neoplasms, Venous Thromboembolism, Low Molecular Weight Heparin

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
s-LMWH
LMWH
Argatroban
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecologic Neoplasms

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

s-LMWH

LMWH

Argatroban

Arm Description

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

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

20mg, injection for 5-10 days

Outcomes

Primary Outcome Measures

VTE rate

Secondary Outcome Measures

Bleeding rate
Infection rate

Full Information

First Posted
October 14, 2016
Last Updated
May 12, 2019
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02935530
Brief Title
Thromboprophylaxis After Surgery for Gynecologic Malignancy in China
Official Title
Effectiveness and Safety of Thromboprophylaxis After Surgery for Gynecologic Malignancy in China
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Neoplasms, Venous Thromboembolism, Low Molecular Weight Heparin, Argatroban

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
s-LMWH
Arm Type
Experimental
Arm Description
2125 I.U. subcutaneous injection for 5-10 days
Arm Title
LMWH
Arm Type
Active Comparator
Arm Description
4250 I.U. subcutaneous injection for 5-10 days
Arm Title
Argatroban
Arm Type
Experimental
Arm Description
20mg, injection for 5-10 days
Intervention Type
Drug
Intervention Name(s)
s-LMWH
Intervention Description
2125KU, subcutaneous injection of 5-10 days
Intervention Type
Drug
Intervention Name(s)
LMWH
Intervention Description
4250KU, subcutaneous injection of 5-10 days
Intervention Type
Drug
Intervention Name(s)
Argatroban
Intervention Description
20mg, injection for 5-10 days
Primary Outcome Measure Information:
Title
VTE rate
Time Frame
30-days from the date of operation
Secondary Outcome Measure Information:
Title
Bleeding rate
Time Frame
30-days from the date of operation
Title
Infection rate
Time Frame
30-days from the date of operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Ma, M.D.
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

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