NCT04360629

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 3, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

April 22, 2020

Last Update Submit

May 30, 2022

Conditions

Advanced Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • operative and postoperative blood loss

    the amount of bleeding

    up to 8 days

Study Arms (3)

high dose TXA

EXPERIMENTAL

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

Drug: Tranexamic Acid

low dose TXA

EXPERIMENTAL

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

Drug: Tranexamic Acid

normal saline

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

Tranexamic AcidDRUG

Tranexamic Acid will be given through central vein

high dose TXAlow dose TXA
normal salineDRUG

normal saline will be given through central vein

normal saline

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sign the informed consent
  • Aged 20-70 years
  • ovarian cancer patients, staged IIIB - C or above
  • \) ASA I - II

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (5)

  • 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.

    PMID: 31865770RESULT

  • 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.

    PMID: 26801659RESULT

  • 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.

    PMID: 24428857RESULT

  • 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.

    PMID: 32224739RESULT

  • Yang X, Chai M, Xia L, He Z, Wu X, Zhang J. Intraoperative use of tranexamic acid to reduce blood loss during cytoreductive surgery for advanced ovarian cancer: A randomized controlled clinical trial. Acta Obstet Gynecol Scand. 2023 Jul;102(7):950-959. doi: 10.1111/aogs.14567. Epub 2023 Apr 7.

    PMID: 37029431DERIVED

MeSH Terms

Interventions

Tranexamic AcidSaline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jun Zhang, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the department of anaesthesiology, Shanghai cancer center

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

June 3, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)