Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Will Change in Blood Loss and Transfusion Requirements.

NCT05024253 | Completed Phase 3

• 1 other identifier: CCHE-BoneT003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ewing Sarcoma of Bone; Osteosarcoma

Keywords

tranexamic acid

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• blood transfusion will be changed by Tranexamic acid when compared with saline or Not.

  during surgery and approximately 1-7 days

Study Arms (2)

patient is receiving Tranexemic acid (TXA )

EXPERIMENTAL

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.

Drug: Tranexamic acid injection

standard treatment (saline)

PLACEBO COMPARATOR

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.

Other: Saline

Interventions

Tranexamic acid injection DRUG

. TXA, a lysine analogue, reversibly binds to the plasminogen lysine receptors and thereby blocks plasminogen from binding to fibrin (tPA can only activate fibrin-bound plasminogen and produce plasmin responsible for cleaving fibrin molecule and dissolving the blood clot)

Also known as: Cyklokapron®

patient is receiving Tranexemic acid (TXA )

Saline OTHER

mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl

Also known as: Salt water

standard treatment (saline)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Malignant bone tumor of the femur and finished neoadjuvant chemotherapy
• Candidate for resection and reconstruction by prosthesis. 3- Age 4-18 years.

You may not qualify if:

• Anatomic location other than femur de
• Reconstruction other than prosthesis
• Allergy to TXA
• Previous history of DVT
• Previous history of renal dysfunction
• Congenital or acquired coagulopathy.
• Congenital or acquired cardiomyopathy.
• Previous history of convulsions.

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (1)

Children's Cancer Hospital Egypt 57357 Cairo, Egypt

Cairo, Egypt

Location

Related Publications (4)

• 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.

  PMID: 32862676 BACKGROUND

• 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.

  PMID: 21358317 BACKGROUND

• 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.

  PMID: 29175569 BACKGROUND

• 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.

  PMID: 29120963 BACKGROUND

MeSH Terms

Conditions

Osteosarcoma

Interventions

Tranexamic Acid; Sodium Chloride; Fluoridation

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

Study Officials

• Ahmed M ELGHONEIMY, MD

  57357 children cancer hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The PI, primary surgeon, anesthesiologist, patient, all assisting surgeons and anesthesiologist as well operating and circulating nurse will be blinded to the study arm to which patient belongs to. Only clinical trial unit and pharmacist will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, double-blinded clinical trial will be done on all included case. They will be divided into two groups based randomly using Block Stratified Randomized Software program, after obtaining informed consent from eligible patient or his caregiver into two Arms: Arm A: patient is not receiving TXA but instead receiving a placebo (saline injection) Arm B: patient is receiving TXA which is colorless solution.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 27, 2021
• Study Start: August 2, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2022-10

Locations

EG (1)