Using tranexamic acid to reduce blood loss during surgery for pelvic tumors
Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
This study is testing if giving tranexamic acid during surgery can help reduce blood loss for patients with pelvic tumors undergoing hemipelvectomy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03128866 on ClinicalTrials.gov |
What this trial studies
This early phase I trial investigates the effectiveness of tranexamic acid in minimizing blood loss in patients with pelvic tumors undergoing hemipelvectomy surgery. The study aims to determine if tranexamic acid can significantly reduce intraoperative and perioperative blood loss, lower the need for blood transfusions, and impact postoperative recovery metrics. Patients are randomized into two groups: one receiving tranexamic acid and the other receiving standard care without the drug. Follow-up assessments are conducted for seven days post-surgery to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates include both pediatric and adult patients with pelvic tumors scheduled for hemipelvectomy at the M.D. Anderson Cancer Center.
Not a fit: Patients with a history of thromboembolic disease or genetic prothrombotic states may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced blood loss and improved recovery for patients undergoing hemipelvectomy surgery.
How similar studies have performed: Previous studies have shown that tranexamic acid can effectively reduce blood loss in various surgical settings, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Valerae O Lewis — M.D. Anderson Cancer Center
- Study coordinator: Valerae O. Lewis, MD
- Email: volewis@mdanderson.org
- Phone: 713-792-5073
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.