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

NCT ID: NCT03128866

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-19
• Study Completion Date: 2026-05-31

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.

Conditions

Pelvic Mass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (tranexamic acid)

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.

Group Type: EXPERIMENTAL

Hemipelvectomy

Intervention Type: PROCEDURE

Undergo hemipelvectomy

Tranexamic Acid

Intervention Type: DRUG

Given IV

Arm II (no tranexamic acid)

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

Group Type: EXPERIMENTAL

Hemipelvectomy

Intervention Type: PROCEDURE

Undergo hemipelvectomy

Interventions

Hemipelvectomy

Undergo hemipelvectomy

Intervention Type: PROCEDURE

Tranexamic Acid

Given IV

Intervention Type: DRUG

Other Intervention Names

Cyclokapron; Cyklokapron; Lysteda; Tranhexamic Acid

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerae O Lewis

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Valerae O. Lewis, MD

Role: CONTACT

volewis@mdanderson.org

713-792-5073

Facility Contacts

Valerae O. Lewis

Role: primary

713-745-4117

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2018-01178

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-0650

Identifier Type: OTHER

Identifier Source: secondary_id

2016-0650

Identifier Type: -

Identifier Source: org_study_id