]>
IRCT20220222054093N1 IRCT 2022-09-24 Shahid Beheshti University of Medical Sciences Comparison of the effectiveness of tranexamic acid drug in simultaneous intravenous and joint administration compared to only joint administration in reducing bleeding after knee joint replacement surgery. Evaluating efficacy and safety of topical and intravenous tranexamicacid for reducing peri/postoperative blood loss in primary Total knee arthroplasty 2022-10-09 anticipated 60 Complete https://irct.ir/trial/65776 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: It does not have unique characteristics, Randomization description: Simple randomization, block.Patients who need knee joint replacement on the morning of the operation are randomly selected to receive tranexamic acid simultaneously intravenously and intra-articularly or only intra-articularly, Blinding description: Participant: On the morning of the operation, we explain to the patient alternately, consecutively and randomly that we intend to use a method to reduce bleeding after the operation, but we do not know whether he is in the group receiving simultaneous venous and joint or only joint. does not have. The surgeon: He does not know about the selection of the patient who is part of the simultaneous intravenous and joint group or only the joint. The main researcher: He does not know about the selection of the patient who is part of the simultaneous intravenous and joint group or only the joint group. Doctors, nurses, physiotherapists, etc.: They don't know about the choice of the patient who is part of the simultaneous intravenous and joint receiving group or only joint. 3 Reduction of bleeding during knee replacement surgery among subjects receiving intravenous and intra-articular tranexamic acid and subjects receiving intra-articular only.. Intervention group: First group: patients who receive a single dose of tranexamic acid intravenously before the start of the operation, and at the end of the operation, a single dose is injected intra-articularly. The second group of patients who receive only one intra-articular dose of tranexamic acid at the end of the operation. This drug is Iranian and manufactured by Caspian Tamim.. Yes - There is a plan to make this available What will be shared: Still undecided - no release schedule yet When: Still undecided - no release schedule yet To whom: Still undecided - no release schedule yet Conditions: Still undecided - no release schedule yet Where to obtain: Still undecided - no release schedule yet How to obtain: Still undecided - no release schedule yet Comments:
public Dr seyed Mehdi Hoseini
Akhtar Hospital, Sharifi Menesh Street,, Rumi BridgeShariati Street
tehran Iran (Islamic Republic of) 1964714953 +98 21 2260 5090 smhaa303@gmail.com Shahid Beheshti University of Medical Sciences scientific seyed mehdi hoseini
Akhtar Hospital, Sharifi Menesh Street,, Rumi BridgeShariati Street
tehran Iran (Islamic Republic of) 1964714953 0098 21 2205090 smhaa303@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with severe knee osteoarthritis whose pain is not controlled by drug treatment and are candidates for joint replacement. no limit no limit Both Patients who have contraindications to receive tranexamic acid 81.41 total knee replacement Treatment - Surgery Intervention group: First group: patients who receive a single dose of tranexamic acid intravenously before the start of the operation, and at the end of the operation, a single dose is injected intra-articularly. The second group of patients who receive only one intra-articular dose of tranexamic acid at the end of the operation. This drug is Iranian and manufactured by Caspian Tamim. Determination of efficacy and safety of intra-articular and intravenous TXA in primary TKA. Timepoint: The intravenous group receives 15 mg per kilogram of the patient's weight intravenously, 5 minutes before the tourniquet is inflated, and 5 minutes after the completion of the skin suture and before the opening of the tourniquet, the same intravenous dose is injected again. The local group receives only 15 mg of tranexamic acid per kilogram of the patient's weight after the completion of the skin suture and 5 minutes before opening the tourniquet. The amount of hemoglobin after the operation is measured at intervals of 6 hours, 12 hours, 24 hours and 48 hours. In addition, the need for blood transfusion is also checked. Method of measurement: Laboratory test. Bone, joint and related tissues research center Approved 2022-08-14 Organizational committee of ethics in biomedical research 3rd floor- Faculty of Medicine -- next to Taleghani Hospital- EvinShahid Chamran Highway-Tehran tehran Tehran Iran (Islamic Republic of)