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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-03

Study Completion Date

2021-12-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Advanced Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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high dose TXA

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Tranexamic Acid will be given through central vein

low dose TXA

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Tranexamic Acid will be given through central vein

normal saline

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

normal saline will be given through central vein

Interventions

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Tranexamic Acid

Tranexamic Acid will be given through central vein

Intervention Type DRUG

normal saline

normal saline will be given through central vein

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes