N/A
N=76
TXA Study in Major Oncologic Surgery
Tranexamic Acid · Cancer · Major Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01980355 ↗Enrolled (actual)
76
Serious AEs
31.6%
Results posted
May 2022
Primary outcome: Primary: Number of Participants Who Required Transfusion — 8; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tranexamic Acid (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corewell Health West
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Required Transfusion |
8; 5 | — |
| SECONDARY Estimated Blood Loss |
450; 365 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01980355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.