RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-05-19

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03128866

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.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Valerae O. Lewis, MD

CONTACT

713-792-5073

volewis@mdanderson.org

Principal Investigator

Valerae O Lewis

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Valerae O Lewis, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2017-05-19

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2017-05-19

Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

Pelvic Mass