Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy S… (NCT03128866) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery
United States80 participantsStarted 2017-05-19
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss