TXA Study in Major Oncologic Surgery

Study Overview
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Brief Summary
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Major surgery can result in blood loss that can require a blood transfusion during and/or after surgery. Tranexamic acid is a medication that was first introduced in the 1960s as a treatment for heavy menstrual bleeding. Over the past 20 years it has been used and studied in patients undergoing open-heart surgery, liver transplantation, and urologic surgery. We believe tranexamic acid may possibly decrease bleeding related to major surgery, resulting in reduced blood loss, lower blood transfusion rates, and possibly decreased hospital costs related to your surgical hospital stay. In this study, you will receive either the drug tranexamic acid or a placebo. The placebo looks like the tranexamic acid, but does not have any active ingredient in it. The treatment you get will be chosen by chance, like flipping a coin. You will have equal chance of being given the tranexamic acid or the placebo. In this study, both the tranexamic acid and the placebo are considered research.

Detailed Description
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Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given the tranexamic acid or the placebo. Neither you nor the study doctor will know which treatment you are getting. You will receive one 1000 mg dose of either tranexamic acid or placebo immediately before surgery. This dose of tranexamic acid or placebo will be given in your vein over 15 minutes. Information from your medical record related to your surgery and recovery time in the hospital will be collected by medical staff assisting with this study and recorded on study forms. These study forms will be labeled with your study number instead of your name. Additionally, if you return to the hospital within 90 days after you went home from the hospital, information about that hospital visit(s) will also be collected from your medical record.

Official Title
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The Effect of Tranexamic Acid on Blood Loss and Transfusion Rates in Major Oncologic Surgery

Conditions
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Tranexamic Acid, Cancer, Major Surgery

Intervention / Treatment
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* Drug: Tranexamic Acid
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects undergoing major oncologic surgery for standard of care purposes (to include, but not limited to: liver resections, radical cholecystectomy, pancreaticoduodenectomy (Whipple procedure), esophagectomy, gastrectomy, colectomy, debulking with hyperthermic intraperitoneal chemotherapy, prostatectomies, nephrectomies and partial nephrectomies) Male or female > 18 years of age Subject agrees to participate in this study and provides informed consent Exclusion Criteria Subjects with a history of hypercoagulopathy, deep vein thrombosis or pulmonary embolism Subjects that are on therapeutic anticoagulation or therapeutic antiplatelet medications at the time of surgery other than Aspirin Subjects with a history of TIA or stroke Subjects with a history of atrial fibrillation Subjects with a known thrombus Baseline creatinine level greater than 2.83 mg/dL Subjects with known hypersensitivity to tranexamic acid Adults unable to provide informed consent Children Pregnant women Prisoners Non-English speaking subjects Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Experimental: Tranexamic Acid<br>1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery. | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Placebo<br>Placebo given over 15 minutes into the vein once prior to surgery. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Required Transfusion | To determine the impact of perioperative administration of tranexamic acid on blood loss and transfusion rates in major oncologic surgery | From time of surgery to 90 days post hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss | Surgical blood loss estimation | From time of surgery to 90 days post hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, surgery, oncology, major, surgical oncology, tranexamic acid