Clinical trial · Interventional
Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Will Change in Blood Loss and Transfusion Requirements.
Does Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Reduce Blood Loss and Transfusion Requirements? A Double-blinded Randomized Controlled Trial
NCT05024253CI-TRIAL-00073802completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to investigate whether previously reported benefit of Tranexamic acid in pediatric orthopedic surgeries could be recapitulated in bone tumor surgeries or not through a double blinded randomized controlled trial done in children cancer hospital 57357.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing Sarcoma of Bone | Bone Ewing Sarcoma | ALIAS | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Saline | Other | — | UNRESOLVED |
| Tranexamic acid injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- patient is receiving Tranexemic acid (TXA )
- description
- Loading dose: Prior to surgical incision, and according to allocated arm, pharmacist will prepare TXA injection at a dose of 10mg/kg diluted in 50ml normal saline (maximum concentration 100mg/ml). Maintenance dose: Throughout surgery, continuous infusion at a dose of 5mg/kg/hour will be given until wound closure.
- interventionNames
- Drug: Tranexamic acid injection
- type
- PLACEBO_COMPARATOR
- label
- standard treatment (saline)
- description
- Loading dose: Prior to surgical incision, and according to allocated arm, pharmacist will prepare 50 ml of 0.9% saline or TXA at a dose of 10mg/kg diluted in 50ml normal saline (maximum concentration 100mg/ml). Maintenance dose: Throughout surgery, continuous infusion of saline will be given until wound closure.
- interventionNames
- Other: Saline
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Malignant bone tumor of the femur and finished neoadjuvant chemotherapy 2. Candidate for resection and reconstruction by prosthesis. 3- Age 4-18 years. Exclusion Criteria: 1. Anatomic location other than femur de 2. Reconstruction other than prosthesis 3. Allergy to TXA 4. Previous history of DVT 5. Previous history of renal dysfunction 6. Congenital or acquired coagulopathy. 7. Congenital or acquired cardiomyopathy. 8. Previous history of convulsions.
References
Publications (4)
- BACKGROUNDLevack AE, McLawhorn AS, Dodwell E, DelPizzo K, Nguyen J, Sink E. Intravenous tranexamic acid reduces blood loss and transfusion requirements after periacetabular osteotomy. Bone Joint J. 2020 Sep;102-B(9):1151-1157. doi: 10.1302/0301-620X.102B9.BJJ-2019-1777.R1. PMID 32862676
- BACKGROUNDDadure C, Sauter M, Bringuier S, Bigorre M, Raux O, Rochette A, Canaud N, Capdevila X. Intraoperative tranexamic acid reduces blood transfusion in children undergoing craniosynostosis surgery: a randomized double-blind study. Anesthesiology. 2011 Apr;114(4):856-61. doi: 10.1097/ALN.0b013e318210f9e3. PMID 21358317
- BACKGROUNDCarabini LM, Moreland NC, Vealey RJ, Bebawy JF, Koski TR, Koht A, Gupta DK, Avram MJ; Northwestern High Risk Spine Group. A Randomized Controlled Trial of Low-Dose Tranexamic Acid versus Placebo to Reduce Red Blood Cell Transfusion During Complex Multilevel Spine Fusion Surgery. World Neurosurg. 2018 Feb;110:e572-e579. doi: 10.1016/j.wneu.2017.11.070. Epub 2017 Nov 22. PMID 29175569
- BACKGROUNDJohnson DJ, Johnson CC, Goobie SM, Nami N, Wetzler JA, Sponseller PD, Frank SM. High-dose Versus Low-dose Tranexamic Acid to Reduce Transfusion Requirements in Pediatric Scoliosis Surgery. J Pediatr Orthop. 2017 Dec;37(8):e552-e557. doi: 10.1097/BPO.0000000000000820. PMID 29120963