Tranexamic Acid During Telescoping Nail Application In Osteogenesis Imperfecta

NCT05321199 | Completed

• 1 other identifier: TXA in OI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effective of intraoperative use of tranexamic acid in reducing blood loss during telescoping nail application in cases of osteogenesis imperfecta.

Conditions

Osteogenesis Imperfecta

Outcome Measures

Primary Outcomes (1)

• Percentage of change in mean blood loss in tranexamic acid group.

  Based on determining the main outcome variable, the estimated minimum required sample size is 40 patients (20 in each group). The sample size was calculated using G\*power software 3.1.9.2., based on the following assumptions: Main outcome variable is intraoperative blood loss in cases of Osteogenesis Imperfecta undergoing telescoping nail application which receive tranexamic acid vs. not received it. Main statistical test is one sided t-test to detect the difference between the two groups. Alpha = 0.05, Power = 0.80, Effect size = 0.81, Allocation ratio= 1

  Baseline

Study Arms (2)

Control patients

EXPERIMENTAL

Closed Envelope for group A (control); patients receiving no tranexamic acid. With Double-Blind Study in which the participants and observers are unaware of who receives tranexamic acid. The total blood loss (TBL), intraoperative blood loss (IBL), postoperative blood loss (PBL), hemoglobin (HGB) levels and Hematocrit value (Hct) on preoperatively (pre-op) and postoperatively, and amount of allogenic blood transfusion were recorded. Furthermore, the general information was also compared between groups.

Drug: Tranexamic acid

Case patients

EXPERIMENTAL

Closed Envelope for group B (case); patients receiving tranexamic acid intravenously and topically. With Double-Blind Study in which the participants and observers are unaware of who receives tranexamic acid. The total blood loss (TBL), intraoperative blood loss (IBL), postoperative blood loss (PBL), hemoglobin (HGB) levels and Hematocrit value (Hct) on preoperatively (pre-op) and postoperatively, and amount of allogenic blood transfusion were recorded. Furthermore, the general information was also compared between groups.

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

Tranexamic acid (TXA) is an antifibrinolytic drug that has been shown to be effective in reducing blood loss and the need for transfusions after several orthopaedic surgeries.

Also known as: Kapron

Case patients; Control patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with osteogenesis imperfecta who will undergo telescoping femoral nail application in Assiut University Hospital - Department of Orthopaedic and Trauma Surgery between April 2022 and March 2023.

You may not qualify if:

• Known allergy to Tranexamic Acid
• History of any acquired disturbances of colour vision
• History of major comorbidities (e.g., severe ischemic heart disease)
• Refusal of blood products
• History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of \<150,000/mm3, or a prolonged partial thromboplastin time, active intravascular clotting \& known congenital thrombophilia
• Preoperative use of anticoagulant therapy within five days before surgery
• Medical Unfit
• Participation in another clinical trial involving pharmaceutical drugs.
• Patients or their relatives who refuse to participate in the study

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, Egypt

Location

Related Publications (10)

• Sillence DO, Senn A, Danks DM. Genetic heterogeneity in osteogenesis imperfecta. J Med Genet. 1979 Apr;16(2):101-16. doi: 10.1136/jmg.16.2.101.

  PMID: 458828 BACKGROUND

• Forlino A, Cabral WA, Barnes AM, Marini JC. New perspectives on osteogenesis imperfecta. Nat Rev Endocrinol. 2011 Jun 14;7(9):540-57. doi: 10.1038/nrendo.2011.81.

  PMID: 21670757 BACKGROUND

• Van Dijk FS, Sillence DO. Osteogenesis imperfecta: clinical diagnosis, nomenclature and severity assessment. Am J Med Genet A. 2014 Jun;164A(6):1470-81. doi: 10.1002/ajmg.a.36545. Epub 2014 Apr 8.

  PMID: 24715559 BACKGROUND

• Palomo T, Fassier F, Ouellet J, Sato A, Montpetit K, Glorieux FH, Rauch F. Intravenous Bisphosphonate Therapy of Young Children With Osteogenesis Imperfecta: Skeletal Findings During Follow Up Throughout the Growing Years. J Bone Miner Res. 2015 Dec;30(12):2150-7. doi: 10.1002/jbmr.2567. Epub 2015 Jun 30.

  PMID: 26059976 BACKGROUND

• Thomas IH, DiMeglio LA. Advances in the Classification and Treatment of Osteogenesis Imperfecta. Curr Osteoporos Rep. 2016 Feb;14(1):1-9. doi: 10.1007/s11914-016-0299-y.

  PMID: 26861807 BACKGROUND

• Hathaway WE, Solomons CC, Ott JE. Platelet function and pyrophosphates in osteogenesis imperfecta. Blood. 1972 Apr;39(4):500-9. No abstract available.

  PMID: 4334923 BACKGROUND

• Armstrong D, VanWormer D, Solomons CC. Increased inorganic serum pyrophosphate in serum and urine of patients with osteogenesis imperfecta. Clin Chem. 1975 Jan;21(1):104-8. No abstract available.

  PMID: 163711 BACKGROUND

• Russell RG, Bisaz S, Donath A, Morgan DB, Fleisch H. Inorganic pyrophosphate in plasma in normal persons and in patients with hypophosphatasia, osteogenesis imperfecta, and other disorders of bone. J Clin Invest. 1971 May;50(5):961-9. doi: 10.1172/JCI106589.

  PMID: 4324072 BACKGROUND

• Jennings JD, Solarz MK, Haydel C. Application of Tranexamic Acid in Trauma and Orthopedic Surgery. Orthop Clin North Am. 2016 Jan;47(1):137-43. doi: 10.1016/j.ocl.2015.08.014.

  PMID: 26614928 BACKGROUND

• Faraoni D, Goobie SM. The efficacy of antifibrinolytic drugs in children undergoing noncardiac surgery: a systematic review of the literature. Anesth Analg. 2014 Mar;118(3):628-36. doi: 10.1213/ANE.0000000000000080.

  PMID: 24557107 BACKGROUND

MeSH Terms

Conditions

Osteogenesis Imperfecta

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Hesham Elbaseet, Lecturer

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 11, 2022
• Study Start: May 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

EG (1)