Osteosarcoma Clinical Trial
Official title:
Does Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Reduce Blood Loss and Transfusion Requirements? A Double-blinded Randomized Controlled Trial
Verified date | October 2022 |
Source | Children's Cancer Hospital Egypt 57357 |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 1, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Children's Cancer Hospital Egypt 57357 Cairo, Egypt | Cairo |
Lead Sponsor | Collaborator |
---|---|
Children's Cancer Hospital Egypt 57357 |
Egypt,
Carabini 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. — View Citation
Dadure 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. — View Citation
Johnson 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. — View Citation
Levack 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative blood loss will be changed by by Tranexamic acid when compared with saline or Not. | will be calculated based on measurement of number and weights of blood-soaked surgical swabs. As well as measurement of total volume of blood collected in suction container, after subtracting volume of saline used for washing wound. | during surgery | |
Primary | postoperative blood loss will be changed by Tranexamic acid when compared with saline or Not. | will be calculated based on measurement of number and weights of blood-soaked surgical swabs. As well as measurement of total volume of blood collected in suction container, after subtracting volume of saline used for washing wound. | after surgery , approximately 1-4 days | |
Secondary | blood transfusion will be changed by Tranexamic acid when compared with saline or Not. | Calculation of blood volume to be transfused (no of units in mls) = (Estimated blood volume ×(target HCT -actual HCT))/HCT of one unit of packed RBCs | during surgery and approximately 1-7 days |
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