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

March 3, 2026 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Tranexamic Acid
Given IV
Other Names:
  • Lysteda
  • Cyklokapron
  • Cyclokapron
  • Tranhexamic Acid
Procedure: Hemipelvectomy
Undergo hemipelvectomy
Experimental: Arm II (no tranexamic acid)
Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
Procedure: Hemipelvectomy
Undergo hemipelvectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss
Time Frame: During first post-operative week
Intraoperative blood loss and perioperative blood loss (total of intraoperative EBL and 1 week drain) will be compared between two groups utilizing two-sample t-test or Wilcoxon rank-sum test. Log-transformation will be taken on the blood loss measurements as appropriate. Multivariable linear regression models will be used to compare two treatment groups in intraoperative and perioperative blood loss by adjusting for significant covariates. Model selection technique, including backward elimination, will be implemented.
During first post-operative week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total number of units of packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, and platelets
Time Frame: At the time of procedure
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of intense care unit (ICU), and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
At the time of procedure
Total number of units of PRBCs, FFP, cryoprecipitate, and platelets
Time Frame: During first post-operative week
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
During first post-operative week
Thromboelastography (TEG)
Time Frame: At baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
At baseline prior to administration of tranexamic acid, after completion of bone cuts, and after completion of closure
Change in laboratory measurements
Time Frame: Baseline up to 7 days post-surgery
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
Baseline up to 7 days post-surgery
Complications including but not limited to venous thromboembolism, stroke, seizure, vision changes, and return to operating room (hematoma, active bleeding)
Time Frame: Up to 7 days post-surgery
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
Up to 7 days post-surgery
Length of ICU and hospital stay
Time Frame: Up to 7 days post-surgery
Two groups will be compared in each of secondary outcome measures utilizing two-sample t-test or Wilcoxon rank-sum test for continuous variables (amount of blood products transfused (during operation and during first postoperative week), lab measurements, length of ICU, and hospital stays) and Chi-square test or Fisher's exact test for categorical variables (complication). Modeling techniques including linear regression (amount of blood products transfused, length of ICU, hospital stays), logistic regression (complication), and mixed effects model (repeatedly measured lab data) will be utilized as appropriate.
Up to 7 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valerae O Lewis, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-0650 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2018-01178 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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