This phase II trial tests whether tranexamic acid works to reduce blood loss during surgery in patients with bony or soft-tissue tumors. The surgical procedure (a resection) used to remove a large bony and soft tissue tumor in people who have abnormal diseases of the primary bones typically causes a large amount of blood loss and requires the need for a blood transfusion. Tranexamic acid works by stopping clots from breaking down and by decreasing unwanted bleeding.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04347122.
PRIMARY OBJECTIVE:
I. To determine if there is any significant difference in perioperative blood loss and blood transfusion rates when tranexamic acid (TXA) is used compared to when it is not used in patients undergoing radical resection of bone and soft tissue sarcomas with endoprosthetic reconstruction.
OUTLINE: Patients undergoing bony tumor surgery are randomized to Group 1 or Group 2. Patients undergoing soft tissue surgery are randomized to Group 3 or Group 4.
GROUP 1: Patients receive TXA intravenously (IV) 10 minutes before and at the end of bony tumor surgery.
GROUP 2: Patients undergo bony tumor surgery.
GROUP 3: Patients receive TXA IV 10 minutes before and at the end of soft tissue sarcoma surgery.
GROUP 4: Patients undergo soft tissue sarcoma surgery.
After completion of study treatment, patients are followed 2-3 weeks, 6 weeks, and 3 months for up to 6 months.
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorKyle R. Sweeney
