Cancer, Major Surgery, Tranexamic Acid
Conditions
Keywords
cancer, surgery, oncology, major, surgical oncology, tranexamic acid
Brief summary
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
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.
Interventions
DRUGTranexamic Acid
OTHERPlacebo
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Required Transfusion | From time of surgery to 90 days post hospital discharge | To determine the impact of perioperative administration of tranexamic acid on blood loss and transfusion rates in major oncologic surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | From time of surgery to 90 days post hospital discharge | Surgical blood loss estimation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid 1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery.
Tranexamic Acid | 39 |
| Placebo Placebo given over 15 minutes into the vein once prior to surgery.
Placebo | 37 |
| Total | 76 |
Baseline characteristics
| Characteristic | Tranexamic Acid | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 11.9 | 63.2 years STANDARD_DEVIATION 11.2 | 61.1 years STANDARD_DEVIATION 11.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 29 Participants | 30 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 39 | 0 / 37 |
| other Total, other adverse events | 0 / 39 | 0 / 37 |
| serious Total, serious adverse events | 11 / 39 | 13 / 37 |
Outcome results
Primary
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
Time frame: From time of surgery to 90 days post hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid | Number of Participants Who Required Transfusion | 8 Participants |
| Placebo | Number of Participants Who Required Transfusion | 5 Participants |
Secondary
Estimated Blood Loss
Surgical blood loss estimation
Time frame: From time of surgery to 90 days post hospital discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Estimated Blood Loss | 450 mL |
| Placebo | Estimated Blood Loss | 365 mL |