Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

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

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.
  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.
  Patients will be randomized to receive TXA (treatment) or No TXA (control).
  Arm 1: Those randomized to TXA (treatment):
  1. Adult patients and pediatric patients > 40 kg will be given a loading dose of 15 mg/kg 30 min prior to skin incision over 15 minutes followed by a 10 mg/kg/hour maintenance infusion during the surgical procedure. The TXA infusion will be discontinued after wound closure.
  2. Pediatric patients (age < 12 and weight 5 - 40 kg) will be given a loading dose of 6.4 mg/kg (maximum 1 gram) dose 30 minutes prior to skin incision over 15 minutes, followed by 2 - 3.1 mg/kg/hr maintenance infusion until skin closure.
  Arm 2: Those randomized to control (no TXA).
  After completion of study treatment, patients are followed up to 7 days.

Eligibility: Inclusion Criteria:
  -  Both pediatric and adult patients can be eligible to participate
  -  Both male and female patients must have a pelvic tumor and are scheduled to have surgery at University of Texas (UT) (MD) Anderson Cancer center that require hemipelvectomy, resulting in pelvic ring disruption
  Exclusion Criteria:
  -  Patient with a history of genetic prothrombotic state
  -  Patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis
  -  Patients with thrombosis of the planned site of resection will not be excluded if the thrombus is caused directly by tumor burden or outflow obstruction
  -  Female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment
  -  Patients will not be eligible if they have a history of color vision defects
  -  Patients will not be eligible if they have a history of retinal vein or artery occlusion
  -  Patients will not be eligible if they have a history of intracranial hemorrhage in past 6 months
  -  Patients will not be eligible if they have a history of hypersensitivity to tranexamic acid
  -  Patients will not be eligible if they present with moderate to severe decrease in creatinine clearance (estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73m2)
  -  Patients will not be eligible if they present or have a history of seizure disorder

Relevance to patient case: not relevant