TXA Study in Major Oncologic Surgery

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Health Hospitals
• Treatments: Tranexamic Acid

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