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IRCT20220724055544N1 IRCT 2023-11-07 Shahid Beheshti University of Medical Sciences Comparison of intravenous and arterial heparin on improvement of radial artery occlusion during catherization The effect of intravenous heparin versus intra-arterial heparin on radial artery blockage during myocardial catheterization via radial access. 2022-11-06 anticipated 200 Complete https://irct.ir/trial/65130 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: An aspect of our design is the consideration of potential age and gender differences in response to heparin. Additionally, we will assess the need for matching based on other relevant factors such as comorbidities, baseline cardiovascular risk factors, and medication use. If our sample size permits, we will match participants in both treatment groups to ensure that our findings account for these potential confounding variables, enhancing the study's validity and relevance, Randomization description: Method of Randomization: Block Design Unit of Randomization: Individual patients Tools Used in Randomization: Computer software designed for randomization, ensuring both randomness and allocation concealment. Random Sequence Building: The computer software will generate a random sequence to assign patients to one of the two treatment groups (intravenous heparin or intra-arterial heparin). Allocation Concealment: Allocation concealment should be carried out to ensure that the treatment assignments are not known to the researchers or participants until the moment of assignment, helping maintain the integrity of the randomization process, Blinding description: The participants will be divided randomly in sealed sheets by someone who is uninformed of the study's specifics. The patients will be fully aware that they will be participating in a study, but not which category they will be assigned to. The operating room operator knows how to inject heparin, but the mechanism is set up in such a way that the doctor doing the procedure does not. Furthermore, the raw data is not made available to the major authors until after the statistical analysis and determination of the outcomes. Following that, participants in the study will be blinded to the type of procedure used in terms of outcomes. The person in charge of monitoring data collection will be in charge of coordinating the operator, the people who follow up on the results, and the person in charge of the study statistics. 2 Condition 1: Radial artery occlusion (RAO). Condition 2: acute coronary syndrome. Intervention 1: Intervention group: Heparin will be injected through the sheet in the arterial route at a dose of 50 units per kilogramme of body weight up to a maximum of 5000 units. Given the country's shortages, the desired heparin may come from Alborz Daru, Royan, Kimidaro, Caspian, or Iran Human. Intervention 2: Venous group: Heparin at a dose of 50 units per kilogram of body weight up to a maximum of 5000 units will be administered into the opposite hand's peripheral vein at no other time. Given the country's shortages, the needed heparin may come from Alborz Daru, Royan, Kimidaro, Caspian, or Iran Human. Yes - There is a plan to make this available What will be shared: If the reviewers require it, a portion of the data containing the main outcome will be published. When: After gathering and analyzing data, most likely beginning in September 2024 To whom: Applicants who do not plan to abuse, in the opinion of the responsible author. This information will be offered to academic and scientific researchers who produce a résumé confirming that they have no conflicts of interest. If necessary, industrial companies can submit a request, and there are approved research projects that will be reviewed by the major writers. Conditions: If the following requirements are met, free individuals will have access to information: 1. Authorship confirmation of the responsible author 2. Providing the reason for the request for raw data 3. No conflict of interest Where to obtain: Corresponding author's work email Mahdiani@gmail.com How to obtain: Emailing and publishing for possible answers and interviews Comments:
public Mohammad Esmail Gheidari
A-arabi
تهران Iran (Islamic Republic of) 1985711151 +98 21 2243 9770 dr.n.nobakht@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohammad Esmail Gheidari
A-arabi
تهران Iran (Islamic Republic of) 1985711151 +98 21 2243 9770 dr.n.nobakht@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who have referred to Taleghani Health Education Center of Shahid Beheshti University of Medical Sciences for diagnostic coronary angiography through radial access. no limit no limit Both Shock Severe heart failure Unstable vital sign S55.10 I21 Unspecified injury of radial artery at forearm level ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Treatment - Drugs Intervention group: Heparin will be injected through the sheet in the arterial route at a dose of 50 units per kilogramme of body weight up to a maximum of 5000 units. Given the country's shortages, the desired heparin may come from Alborz Daru, Royan, Kimidaro, Caspian, or Iran Human. Venous group: Heparin at a dose of 50 units per kilogram of body weight up to a maximum of 5000 units will be administered into the opposite hand's peripheral vein at no other time. Given the country's shortages, the needed heparin may come from Alborz Daru, Royan, Kimidaro, Caspian, or Iran Human. Radial artery occlusion. Timepoint: Barbeau test and arterial ultrasound are both performed 24 hours after the study to find the main result. Method of measurement: Radial artery occlusion is measured by Barbeau criterion or arterial ultrasound. The amount of heparin. Timepoint: The amount of heparin is measured by the operator during the operation and recorded immediately after. Method of measurement: The operator's heparin usage is pooled and announced by unit. Prothrombin time. Timepoint: Immediately after the intervention. Method of measurement: Prothrombin time by the Fisher brand laboratory kit. Partial Thromboplastin time (PTT). Timepoint: Immediately after the intervention. Method of measurement: Partial Thromboplastin time by the Fisher brand laboratory kit. International unit ratio (INR). Timepoint: Immediately after the intervention. Method of measurement: International unit of dividing pt by the expected amount of the person at the desired age. Bleeding time. Timepoint: Immediately after the intervention. Method of measurement: Bleeding time by the bt kit of bt-labtatory company. Shahid Beheshti University of Medical Sciences Approved 2022-10-18 Ethics committee of Shiraz University of Shahid Beheshti University of Medical Sciences Kudakyar St. Tehran Tehran Iran (Islamic Republic of)