Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer

May 30, 2022 updated by: Jun Zhang

Tranexamic acid has been used in surgery for more than 30 years. It's effect on reducing bleeding and blood transfusing has been demonstrated.

In our hospital, the amount of cytorsductive surgery for ovarian cancer is big. During the perioperation , bleeding probability is high, and the supply of blood products is limited. In order to reduce bleeding, we're planning to use tranexamic acid in the operations.

In this experiment, we will observe the efficacy of tranexamic acid in cytoreductive surgery for ovarian cancer, find the best dosage which can reach the desired effect, and the possible side-effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We performed a single blind, prospective, randomised control trial (RCT) . The patients randomised assigned to three groups. Low dose TXA, high dose TXA or a placebo of IV saline which will be infused prior to skin incision in patients undergoing elective cytorsductive surgery for ovarian cancer .

Intraoperative blood loss will be estimated by the volume in the suction drains and by weighing the swabs. Postoperative blood loss will be estimated by the volume in the drains.

The other secondary outcomes will be inclued perioperation transfusion volume, thromboembolic complications, ICU length of stay (LOS), hospital LOS, adverse thrombogenic events within 30 days, 30-day all-cause readmission and so on.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

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
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Shanghai Cancer Center, Fudan University

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

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. sign the informed consent
  2. Aged 20-70 years
  3. ovarian cancer patients, staged IIIB - C or above

3) ASA I - II

Exclusion Criteria:

  1. tranexamic acid allergy
  2. pregnancy and lactation
  3. only lymph node metastasise
  4. history of mental disorder, immune system disorder
  5. history of epilepsy, dyschromatopsia
  6. arrhythmia
  7. history of renal insufficiency
  8. thrombosis related disease
  9. Hb < 90 g/dL
  10. using anticoagulant drugs (not including aspirin discontinuation 1 week
  11. having participated in other clinical trials, or refusing to join the research.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high dose TXA
TXA will be given as a 20mg/kg bolus followed by infusion of 5mg/ kg/hr per our anesthesia protocol
Drug: Tranexamic Acid
Tranexamic Acid will be given through central vein
Experimental: low dose TXA
TXA will be given as a 10mg/kg bolus followed by infusion of 1mg/ kg/hr per our anesthesia protocol
Drug: Tranexamic Acid
Tranexamic Acid will be given through central vein
Placebo Comparator: normal saline
saline will be given as a 4ml/kg bolus followed by infusion of 1ml/ kg/hr per our anesthesia protocolprotocol4ml/kg
Drug: normal saline
normal saline will be given through central vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative and postoperative blood loss
Time Frame: up to 8 days
the amount of bleeding
up to 8 days

Collaborators and Investigators

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

Sponsor

Jun Zhang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 3, 2020

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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