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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Advanced Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sign the informed consent Aged 20-70 years ovarian cancer patients, staged IIIB - C or above 3) 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dose TXA<br>TXA will be given as a 20mg/kg bolus followed by infusion of 5mg/ kg/hr per our anesthesia protocol | Drug: Tranexamic Acid<br>* Tranexamic Acid will be given through central vein<br>|
| Experimental: low dose TXA<br>TXA will be given as a 10mg/kg bolus followed by infusion of 1mg/ kg/hr per our anesthesia protocol | Drug: Tranexamic Acid<br>* Tranexamic Acid will be given through central vein<br>|
| Placebo Comparator: normal saline<br>saline will be given as a 4ml/kg bolus followed by infusion of 1ml/ kg/hr per our anesthesia protocolprotocol4ml/kg | Drug: normal saline<br>* normal saline will be given through central vein<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative and postoperative blood loss | the amount of bleeding | up to 8 days |