The effect of intravenous heparin versus intra-arterial heparin on radial artery blockage during myocardial catheterization via radial access.

The effect of intravenous heparin versus intra-arterial heparin on radial artery occlusion during coronary catheterization via radial access.

The study is a double-blind, parallel group, randomized clinical trial. It is single-center, with a concealed randomization method using computer-generated sequences. The study includes a sample size of 200 patients.

Diagnostic coronary angiography through central radial access at the Taleghani Health Education Center of Shahid Beheshti University of Medical Sciences. Intravenous patients will receive 50 units per/kg up to 5000 units of heparin. This group will receive heparin through the opposite arm's vein. The intra-arterial group will receive the same amount of heparin. Both groups receive normal saline serum from a different vein than drug injection. In this study, the angiographer won't know about the heparin injection.

Criteria for inclusion: 1. A candidate for coronary angiography 2. According to expert diagnosis, from the radial artery Criteria for exclusion: 1. A non-cardiac life-threatening condition 2. Instability of vital signs

In the intravenous group, patients will be given heparin at a rate of 50 units per kilogram of body weight, up to a maximum of 5000 units. Heparin will be injected into this group via the opposite arm's peripheral vein. The intra-arterial group will also get the heparin via the arterial route's sheet. In both groups, normal saline will be administered through a vein other than the one used for medication injection.

Prothrombin Time, partial thromboplastin time (PTT), international normalized ratio (INR), Bleeding Time (BT), Incidence of RAO based on the Bandeau test, radial artery occlusion based on Color Doppler sonography, and the amount of prescribed heparin.

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.

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.

If the reviewers require it, a portion of the data containing the main outcome will be published.

After gathering and analyzing data, most likely beginning in September 2024

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.

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

Corresponding author's work email Mahdiani@gmail.com

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