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

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    80
  • sponsor
    M.D. Anderson Cancer Center
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Updated on 23 October 2022
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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.

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.

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.

Details
Condition Pelvic Mass
Treatment Tranexamic Acid, Hemipelvectomy, Hemipelvectomy
Clinical Study IdentifierNCT03128866
SponsorM.D. Anderson Cancer Center
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

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) Monroe Dunaway (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
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