NCT03128866

Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery

Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Mass

Interventions

Type	Name	Description
PROCEDURE	Hemipelvectomy	Undergo hemipelvectomy
DRUG	Tranexamic Acid	Given IV

Timeline

• Start date: 2017-05-19
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2017-04-25
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study