Tranexamic Acid in Surgery of Advanced Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women undergoing surgery for advanced ovarian cancer.

Official Title
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Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: 0.9% NaCl solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females ages 18 or older with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery. Understand and speak Swedish Accept participation in the study after written and verbal information and sign informed consent. Exclusion Criteria: Allergy to tranexamic acid Having had tranexamic acid within the recent 30 days Previous or present episode of thromboembolic events . Previous or present treatment within the recent 3 months with anticoagulant. Previous or present known coagulopathy Myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin. Significant renal failure with serum-creatinine > 250 µmol/l. Severe psychiatric dysfunction or mentally substantially disabled.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The Tranexamic acid group<br>The group of women receiving Tranexamic acid intravenously immediately before the surgery | Drug: Tranexamic acid<br>* Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to skin incision at surgery<br>* Other names: ATC-code B02AA02;|
| Placebo Comparator: The placebo group<br>The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery | Drug: 0.9% NaCl solution<br>* 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before skin incision at surgery.<br>* Other names: ATC-code B05BB01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Bleeding Volume | Estimation of total blood loss was based on the estimation of the Hb balance method (Brecher, et al.1997) with the assumption that the body blood volume was normalised on the fifth postoperative day. The haemoglobin level was assessed preoperatively and on the fifth postoperative day. The predicted blood volume (PBV, l) was calculated according to the method described by Nadler et al. (1962), using body weight and height. The extravasation of haemoglobin was calculated taking into account allogenic transfused haemoglobin. Total blood loss perioperatively was related to the patient's preoperative haemoglobin value. Blood loss due to haematomas or a reoperation within the first five days after surgery was also considered. | From start of operation to discharge from hospital, up to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Receiving Blood Transfusions | Total number of RBC-transfused women in each group | From start of operation to discharge from hospital, up to 5 weeks | 
| Number of Units of Red Blood Cells (RBC) Transfused | Total number of red blood cells (RBC) transfused across all participants | From start of operation to discharge from hospital, up to 5 weeks | 
| Median Number of Transfused Units of Red Blood Cells (RBC) | Median number of red blood cells transfused among those who received RBC transfusions | From start of operation to discharge from hospital, up to 5 weeks | 
| Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively | Thromboembolic events including arterial thrombosis, muscle vein thrombosis, superficial and deep venous thrombosis. | From time of operation to 5 weeks postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumor of ovary, Surgical blood loss, Postoperative blood loss, Preventive therapy, Thromboembolism