Tranexamic Acid During Telescoping Nail Application In Osteogenesis Imperfecta
NCT ID: NCT05321199
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-05-01
2023-11-30
Brief Summary
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Detailed Description
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The surgical treatment of osteogenesis imperfecta (OI) is negatively influenced by clinical features such as osteoporosis, limb deformities and bone changes caused by bisphosphonate therapy. Blood loss during telescoping nail application in patients with Osteogenesis Imperfecta is a serious problem especially patients with Osteogenesis Imperfecta type III are considered at high risk of blood loss during surgery because of capillary fragility and an altered platelet function.
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.
However, the effectiveness of tranexamic acid use in application of telescoping nail in osteogenesis imperfecta still remains unclear and no previously available study about this subject. The purpose of this study is to assess the effectiveness of intraoperative use of intravenous (IV) tranexamic acid in reducing total blood loss and transfusion rates for patients who will be operated with telescoping nail application for osteogenesis imperfecta.
Each patient with osteogenesis imperfecta, who consecutively will undergo telescoping femoral nail application with intraoperative use of tranexamic acid during 2022-2023, will be recruited in the study.
A total of 40 patients undergoing telescoping femoral nail application for osteogenesis imperfecta will be including in a prospective randomized study.
Taking detailed history and full clinical examination to exclude the presence of any medical disorder that prevents use of Tranexamic acid. Preoperative lab investigations are Complete Blood Count (CBC) to determine Hemoglobin HB level and Hematocrit value preoperatively.
Operations will be performing under general anesthesia, no tourniquet is using, and the intraoperative regime will be the same for all patients. Patients will be dividing into 2 groups; in group A (control); patients receiving no tranexamic acid, in group B (case); patients receiving 10-15mg/kg or 1g of tranexamic acid intravenously, given 30 minutes before skin incision in telescoping femoral nail application followed by another dose of intravenous tranexamic acid (10-15mg/kg; body weight average 1g) at time of wound closure.
Intraoperative blood loss shall be quantified by measuring irrigation fluid and the weight of surgical sponges used to dry the field intraoperatively by the researcher plus amount of blood in suction drain.
Comparison of blood loss between patients with first femoral osteotomy and patients with previous recurrent femoral osteotomies.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SCREENING
NONE
Study Groups
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Control patients
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.
Tranexamic acid
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.
Case patients
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.
Tranexamic acid
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.
Interventions
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Tranexamic acid
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Ammar Jamal Aldeen Mohammed Mohammed
Resident doctor
Principal Investigators
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Hesham Elbaseet, Lecturer
Role: STUDY_DIRECTOR
Assiut University
Locations
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Assiut University Hospitals
Asyut, , Egypt
Countries
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References
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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.
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.
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.
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.
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.
Hathaway WE, Solomons CC, Ott JE. Platelet function and pyrophosphates in osteogenesis imperfecta. Blood. 1972 Apr;39(4):500-9. No abstract available.
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.
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.
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.
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.
Other Identifiers
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TXA in OI
Identifier Type: -
Identifier Source: org_study_id