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IRCT20221104056393N1 IRCT 2023-06-27 Shahid Beheshti University of Medical Sciences The Effect of Ascorbic Acid on the blood loss in Total Knee Arthroplasty Evaluation the Effect of Ascorbic Acid compared to normal saline on the hidden blood loss in total knee arthroplasty 2023-06-18 anticipated 100 Complete https://irct.ir/trial/70251 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 alternately (one in between) assigned into two groups in a 1:1 ratio, Blinding description: In this double-blind study, patients and the data collector are blinded. Patients are kept unaware of their group assignment and the intervention they are receiving. Patients in both groups receive serums with covers so that the content will not be visible to the patients. Both the treatment and control groups receive identical instructions and support. The data collector is kept blind to the group assignment of each patient. Collecting data including laboratory values after the surgery and clinical examinations will be performed without knowing the intervention done for the patient and only according to their records number. N/A Total Knee Arthroplasty. Intervention 1: Control group: The patients in the control group will receive only normal saline. Intervention 2: 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 10 mL) will be infused postoperatively during the first 12h. 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 Seyed Morteza Kazemi
Azar dead end alley , Sharifi Manesh street, Pole Roomi, Tajrish
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2200 1072 kazemimort@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Morteza Kazemi
Azar dead end alley , Sharifi Manesh street, Pole Roomi, Tajrish
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2200 1072 kazemimort@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Candidates of total knee arthroplasty patients who provide written informed consent to be included 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 atrial fibrillation being in pregnancy or in the lactation period drug abusers or alcoholics severe renal dysfunction severe infection the preoperative hemoglobin less than 10 g/dL diagnosis of inflammatory arthritis like rheumatoid arthritis, pigmented villonodular synovitis and etc clotting disorders including abnormal PT, PTT or INR M17.9 Osteoarthritis of knee, unspecified Treatment - Surgery Treatment - Surgery Control group: The patients in the control group will receive only normal saline. 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 10 mL) will be infused postoperatively during the first 12h. 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 2023-06-14 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)