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IRCT20221104056393N2 IRCT 2023-08-12 Shahid Beheshti University of Medical Sciences The Effect of Ascorbic Acid on the blood loss in Total Hip Arthroplasty Evaluation the Effect of Ascorbic Acid compared to normal saline on the hidden blood loss in total hip arthroplasty 2023-08-01 anticipated 70 Complete https://irct.ir/trial/71109 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this randomized controlled clinical trial, the patients will be consecutively and in a 1:1 ratio assigned into two groups based on a simple randomization method. The surgeon is informed about the assigned group for each person by a sealed letter, Blinding description: In this double-blind study, patients are evaluated with random ID numbers assigned to them by the researcher. Patients and the data collector will be blind. Patients are kept unaware of their group assignment and the intervention they are receiving. Both the treatment and control groups receive identical instructions and support. The data collector is kept blind to the group assignment of each patient and will record the results only according to the patient IDs. N/A Total Hip Arthroplasty. Intervention 1: Intervention group: The patients in the intervention group will receive the first ascorbic acid dose (1 g in 10 mL) at the beginning of the surgery. Another dose of ascorbic acid (1 g in 10 mL) will be infused during the surgery. After the surgery, an additional dose of ascorbic acid (1 g in 10mL) will be infused postoperatively during the first 12h. Intervention 2: Control group: The patients in the control group will receive only normal saline. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared after making the individuals undetectable When: Access will be granted 6 months after the results of the study are published. To whom: Researchers and medical specialist Conditions: based on the Ministry of Health and Medical Education criteria for clinical trials Where to obtain: Orthopedic department of Shahid Beheshti Medical University How to obtain: The data will be provided after reviewing the researcher's request and providing sufficient documentation of their research and the reason for using the data. Comments:
public Seyyed Mohammad Qoreishi
Azar dead end alley , Sharifi Manesh street, Pole Roomi, Tajrish
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2200 1072 qoreishy@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyyed Mohammad Qoreishi
Azar dead end alley , Sharifi Manesh street, Pole Roomi, Tajrish
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2200 1072 qoreishy@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Candidates of total hip arthroplasty due to osteoarthritis Patients who provide written informed consent to participate in this study. no limit no limit Both history of thromboembolic events like deep vein thrombosis or pulmonary embolism history of cardiovascular disease like myocardial infarction or atrialfibrillation clotting disorders including abnormal PT, PTT or INR being in pregnancy or in the lactation period drug abusers or alcoholics severe renal dysfunction severe infection the preoperative hemoglobin of < 10 g/dL diagnosis of inflammatory arthritis like rheumatoid arthritis, pigmented villonodular synovitis and etc M16.1 Unilateral primary osteoarthritis of hip Treatment - Surgery Treatment - Surgery Intervention group: The patients in the intervention group will receive the first ascorbic acid dose (1 g in 10 mL) at the beginning of the surgery. Another dose of ascorbic acid (1 g in 10 mL) will be infused during the surgery. After the surgery, an additional dose of ascorbic acid (1 g in 10mL) will be infused postoperatively during the first 12h. Control group: The patients in the control group will receive only normal saline. Total blood loss. Timepoint: Before intervention, 24h after intervention. Method of measurement: amount of Hemoglobin drop. Transfusion rate. Timepoint: Before the intervention, 24h after the intervention. Method of measurement: number of units of blood transfused. Shahid Beheshti University of Medical Sciences Approved 2023-06-27 Ethics committee of Shahid Beheshti University of Medical Sciences Azar dead end alley, Sharifi Manesh street., Pole Roomi, Tajrish Tehran Tehran Iran (Islamic Republic of)