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

Primary Purpose

Advanced Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tranexamic Acid
normal saline
Sponsored by
Jun Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Advanced Ovarian Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanghai Cancer Center, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

high dose TXA

low dose TXA

normal saline

Arm Description

TXA will be given as a 20mg/kg bolus followed by infusion of 5mg/ kg/hr per our anesthesia protocol

TXA will be given as a 10mg/kg bolus followed by infusion of 1mg/ kg/hr per our anesthesia protocol

saline will be given as a 4ml/kg bolus followed by infusion of 1ml/ kg/hr per our anesthesia protocolprotocol4ml/kg

Outcomes

Primary Outcome Measures

operative and postoperative blood loss
the amount of bleeding

Secondary Outcome Measures

Full Information

First Posted
April 22, 2020
Last Updated
May 30, 2022
Sponsor
Jun Zhang
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1. Study Identification

Unique Protocol Identification Number
NCT04360629
Brief Title
Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer
Official Title
Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jun Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Ovarian Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high dose TXA
Arm Type
Experimental
Arm Description
TXA will be given as a 20mg/kg bolus followed by infusion of 5mg/ kg/hr per our anesthesia protocol
Arm Title
low dose TXA
Arm Type
Experimental
Arm Description
TXA will be given as a 10mg/kg bolus followed by infusion of 1mg/ kg/hr per our anesthesia protocol
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
saline will be given as a 4ml/kg bolus followed by infusion of 1ml/ kg/hr per our anesthesia protocolprotocol4ml/kg
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
Tranexamic Acid will be given through central vein
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
normal saline will be given through central vein
Primary Outcome Measure Information:
Title
operative and postoperative blood loss
Description
the amount of bleeding
Time Frame
up to 8 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: sign the informed consent Aged 20-70 years ovarian cancer patients, staged IIIB - C or above 3) ASA I - II Exclusion Criteria: tranexamic acid allergy pregnancy and lactation only lymph node metastasise history of mental disorder, immune system disorder history of epilepsy, dyschromatopsia arrhythmia history of renal insufficiency thrombosis related disease Hb < 90 g/dL using anticoagulant drugs (not including aspirin discontinuation 1 week having participated in other clinical trials, or refusing to join the research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Cancer Center, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31865770
Citation
Zakhari A, Sanders AP, Solnik MJ. Tranexamic acid in gynecologic surgery. Curr Med Res Opin. 2020 Mar;36(3):513-520. doi: 10.1080/03007995.2019.1708533. Epub 2020 Jan 6.
Results Reference
result
PubMed Identifier
26801659
Citation
Kietpeerakool C, Supoken A, Laopaiboon M, Lumbiganon P. Effectiveness of tranexamic acid in reducing blood loss during cytoreductive surgery for advanced ovarian cancer. Cochrane Database Syst Rev. 2016 Jan 23;2016(1):CD011732. doi: 10.1002/14651858.CD011732.pub2.
Results Reference
result
PubMed Identifier
24428857
Citation
Lundin ES, Johansson T, Zachrisson H, Leandersson U, Backman F, Falknas L, Kjolhede P. Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study. Acta Obstet Gynecol Scand. 2014 Apr;93(4):335-44. doi: 10.1111/aogs.12333. Epub 2014 Feb 25.
Results Reference
result
PubMed Identifier
32224739
Citation
Heyns M, Knight P, Steve AK, Yeung JK. A Single Preoperative Dose of Tranexamic Acid Reduces Perioperative Blood Loss: A Meta-analysis. Ann Surg. 2021 Jan 1;273(1):75-81. doi: 10.1097/SLA.0000000000003793.
Results Reference
result

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

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