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

Jun Zhang

Status: Completed

Conditions: Advanced Ovarian Cancer

Treatments: Drug: normal saline; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04360629

V1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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151 participants in 3 patient groups, including a placebo group

high dose TXA

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

low dose TXA

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: normal saline