Clinical trial · Interventional
Tranexamic Acid in Reducing Blood Loss in Patients With Pelvic Tumors Undergoing Hemipelvectomy Surgery
Reducing Blood Loss in Hemipelvectomy Surgery With the Use Tranexamic Acid (TXA)
NCT03128866CI-TRIAL-00104662active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pelvic Mass | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemipelvectomy | Procedure | — | UNRESOLVED |
| Tranexamic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (tranexamic acid)
- description
- 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.
- interventionNames
- Procedure: Hemipelvectomy
- Drug: Tranexamic Acid
- type
- EXPERIMENTAL
- label
- Arm II (no tranexamic acid)
- description
- Patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Procedure: Hemipelvectomy
Primary outcomes (1)
- measure
- Total perioperative blood loss defined as the total intraoperative estimation of blood (EBL) loss
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.