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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Early Phase 1

Conditions: Pelvic Mass

Treatments: Drug: Tranexamic Acid; Procedure: Hemipelvectomy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03128866

NCI-2018-01178 (Registry Identifier)

2016-0650 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both pediatric and adult patients can be eligible to participate
• Cognitively impaired and non-English speakers 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Arm I (tranexamic acid)

Experimental group

Description:

Patients receive tranexamic acid IV over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity.

Treatment:

Procedure: Hemipelvectomy

Drug: Tranexamic Acid

Arm II (no tranexamic acid)

Experimental group

Description:

Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.

Treatment:

Procedure: Hemipelvectomy