Tranexamic Acid During Telescoping Nail Application In Osteogenesis Imperfecta

Osteogenesis Imperfecta Clinical Trial

Official title:

Efficacy of Intraoperative Use of Tranexamic Acid in Reducing Blood Loss During Telescoping Nail Application in Osteogenesis Imperfecta - Randomized Control Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05321199
• Other study ID #: TXA in OI
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Osteogenesis imperfecta (OI) is a rare inherited pathology that consists of abnormal type one collagen synthesis that affects all structures in the body. The most important and early sign of this pathology is the appearance of fractures after low-energy trauma, progressive bowing of long bones, joint instability, and chronic bone pain. The most used classification is the one created by Sillence that initially had four types and now is expended to more than 15 types. A new nomenclature was published in 2014 in order to simplify the classification and help understand such an intricate pathology. Clinically, all systems in the body are affected, but changes to the musculoskeletal are the most severe; besides, a variable degree of bone brittleness is present. Patients are suffering from severe hyperlaxity, short stature, scoliosis, progressive bowing of the limbs, and chronic bone pain due to continuous microfractures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University Hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Am J Med Genet A. 2015 May;167A(5):1178. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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