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

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.

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Key information

Conditions

Advanced Ovarian Cancer

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Tranexamic Acid

Drug

Tranexamic Acid will be given through central vein

normal saline

Drug

normal saline will be given through central vein

Primary outcomes

operative and postoperative blood loss

Time frame: up to 8 days

the amount of bleeding

Sponsors and collaborators

Lead sponsor

Jun Zhang

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Apr 24, 2020
Registry last updated: Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed