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Advanced Ovarian CancerNCT04360629

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

A study testing Tranexamic Acid and normal saline in people with Advanced Ovarian Cancer, run by Jun Zhang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Advanced Ovarian Cancer
What is being tested?
Tranexamic Acid and normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
151 participants
Where
1 siteChina
Study dates
3 Jun 2020to 30 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • tranexamic acid allergy
  • pregnancy and lactation
  • only lymph node metastasise
  • history of mental disorder, immune system disorder
  • history of epilepsy, dyschromatopsia
  • arrhythmia
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Cancer Center, Fudan University

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

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.

Read the 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.

Being tested
Tranexamic Acid, normal saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic AcidDrug

    Tranexamic Acid will be given through central vein

  • normal salineDrug

    normal saline will be given through central vein

Study groups in NCT04360629
Study groupRoleWhat they receive
high dose TXAExperimentalTXA will be given as a 20mg/kg bolus followed by infusion of 5mg/ kg/hr per our anesthesia protocol
Receives: Drug: Tranexamic Acid
low dose TXAExperimentalTXA will be given as a 10mg/kg bolus followed by infusion of 1mg/ kg/hr per our anesthesia protocol
Receives: Drug: Tranexamic Acid
normal salinePlacebo comparatorsaline will be given as a 4ml/kg bolus followed by infusion of 1ml/ kg/hr per our anesthesia protocolprotocol4ml/kg
Receives: Drug: normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. operative and postoperative blood loss

    the amount of bleeding

    Measured: up to 8 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start3 Jun 2020
  3. Primary completion30 Dec 2021
  4. Study completion30 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04360629
Sponsor's protocol ID
V1.0
Status last verified
May 2022
First submitted
22 Apr 2020
Last updated
1 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31865770

  • 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.

    PubMed 26801659

  • 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.

    PubMed 24428857

  • 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.

    PubMed 32224739

  • 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.

    PubMed 37029431

Questions about this trial

What is this clinical trial studying?

A study testing Tranexamic Acid and normal saline in people with Advanced Ovarian Cancer, run by Jun Zhang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

operative and postoperative blood loss (time frame: up to 8 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04360629, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

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