Spots Global Cancer Trial Database for Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery

Study Description

Brief Summary: This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery.

Detailed Description: PRIMARY OBJECTIVES: I. To determine if the use of tranexamic acid results in a significant reduction in intraoperative and perioperative blood loss. SECONDARY OBJECTIVES: I. To determine if use of tranexamic acid lowers the amount of blood products transfused in hemipelvectomy surgeries and during first postoperative week. II. To determine if the use of tranexamic acid has an effect on laboratory (lab) measurements preoperatively through postoperative day 7. III. To determine if use of tranexamic acid has an effect on complication, length of intensive care unit (ICU), and hospital stays. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (TRANEXAMIC ACID): Patients receive tranexamic acid intravenously (IV) over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity. ARM II (NO TRANEXAMIC ACID): Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 7 days.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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