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IRCT20221228056952N1 IRCT 2023-12-30 Mashhad University of Medical Sciences Using tourniquet and IV tranexamic acid in unilateral Total Knee Arthroplasty (TKA) surgery The effect of using tourniquet and IV tranexamic acid on clinical outcomes and blood loss in unilateral Total Knee Arthroplasty (TKA) surgery: a randomized clinical trial 2023-12-29 anticipated 168 Complete https://irct.ir/trial/67663 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random assignment of eligible people to the study is done by a person who is independent from the research team and is not involved in the process of treatment, follow-up of participants, data collection and recording. In order to achieve an equal number of patients in the groups under study and the least amount of difference in the number of people participating in the groups, the allocation of people will be done by block randomization. Due to the fact that 4 groups will be examined and compared in this research, blocks of 4 were used. Based on this and according to the calculated sample size, 42 blocks of four were considered. After the eligible subjects were determined to enter the study and their informed consent in the study was ensured, they were randomly assigned to the groups under study (the group using intravenous TXA, the group using topical TXA in solution and control group) will be allocated. Randomization will be performed using a computerized random assignment sequence. The belonging of people/patients to the groups under study will be blind for the patient, doctor/interventionist, and the person evaluating the results, so that first 42 envelopes containing 4 cards with letter labels indicating the belonging of the patients to the groups under study, will be prepared and given inside opaque envelopes. These envelopes are placed by the secretary of the department, who are not involved in research and recording the outcomes under study. Data before and after the surgical process will be collected and recorded by researchers other than the surgeon, Blinding description: The belonging of people/patients to the groups under study will be blind to the evaluators of outcomes and the biostatistician who analyzes the data. We will assign unique identifiers or codes to each participant that do not reveal their treatment allocation. These codes will be used in all documentation instead of identifiable information. The actual treatment allocation for each participant will be kept in sealed, opaque envelopes or stored in a secure, restricted-access database. Only specific personnel (e.g., an independent coordinator) will have access to these codes. Outcome evaluators will use forms that contain only the coded identifiers, ensuring no direct indication of treatment allocation is present in the data collection materials. Data collected by evaluators will be stored separately from any information that discloses treatment allocation. This separation will prevent unintentional unblinding during data handling. Data provided to the biostatistician for analysis will only include the coded identifiers and outcome data without any reference to treatment allocation. Results presented to the biostatistician for interpretation should maintain the blinding by using only the coded identifiers without any treatment-related information. 3 Condition 1: Knee osteoarthritis. Condition 2: Unilateral total knee arthroplasty. Intervention 1: Intervention group 1: 1000 mg of intravenous tranexamic acid 30 minutes prior to the incision plus 1000 mg of intravenous tranexamic acid during wound closure. Using tourniquet during the procedure. Intervention 2: Control group: Without tranexamic acid injection and without tourniquet application. Intervention 3: Intervention group 2: Without tranexamic acid injection and with tourniquet application. Intervention 4: Intervention group 3: 1000 mg of intravenous tranexamic acid 30 minutes prior to the incision plus 1000 mg of intravenous tranexamic acid during wound closure. Without using tourniquet during the procedure. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality
public Dr. Mohammad-Hossein Ebrahimzadeh
Ahmadabad street, Ghaem hospital
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2638 Ebrahimzadehmh@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Mohammad-Hossein Ebrahimzadeh
Ahmadabad street, Ghaem hospital
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2638 Ebrahimzadehmh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who refer to Ghaem hospital knee orthopedic clinic Indicated for unilateral total knee arthroplasty (TKA) surgery 18 years 60 years Both allergy to TXA Active thromboembolic disease Seizure disorder Prior cerebrovascular accident Cardiac stents or a history of thromboembolic disease Prior renal disorder (glomerular filtration rate < 30 ml/min/1.73m2) M17.1 Unilateral primary osteoarthritis of knee Treatment - Surgery Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group 1: 1000 mg of intravenous tranexamic acid 30 minutes prior to the incision plus 1000 mg of intravenous tranexamic acid during wound closure. Using tourniquet during the procedure. Control group: Without tranexamic acid injection and without tourniquet application Intervention group 2: Without tranexamic acid injection and with tourniquet application Intervention group 3: 1000 mg of intravenous tranexamic acid 30 minutes prior to the incision plus 1000 mg of intravenous tranexamic acid during wound closure. Without using tourniquet during the procedure. Blood loss volume. Timepoint: After surgery. Method of measurement: Postoperatively, blood loss will be calculated on the basis of the validated Gross formula, which includes sex, height, and weight, as well as pre-operative and postoperative day 2 hematocrit values with correction for any volume of blood administered. Surgeon satisfaction with visualization during the procedure. Timepoint: After surgery. Method of measurement: Using a 10-point visualization scale, with 0 categorized as ‘‘poor’’ and 10 categorized as ‘‘good.’’ This will be completed by the operative surgeon at the end of the case. Clinical outcomes. Timepoint: 2 and 6 months follow-up after surgery. Method of measurement: Pain score using Visual analogue scale (VAS), a 10-point visualization scale. Knee functional questionnaires of Oxford Knee Score, and WOMAC. Mashhad University of Medical Sciences Approved 2023-06-27 The Ethics Committee for Research at the Faculty of Medicine, Mashhad University of Medical Sciences Mashhad, Daneshgah street, Central Organization of Mashhad University of Medical Sciences, Ghoreishi Building. Mashhad Razavi Khorasan Iran (Islamic Republic of)