Percutaneous Coronary Intervention Clinical Trial
Official title:
Effect of Hemostatic Device With Quantitative Pressure on Radial Artery Hemostasis After Percutaneous Coronary Intervention：a Randomized Controlled Trial
The objective of this clinical trial is to compare the hemostatic effect of 2 hemostatic devices with or without quantitative pressure on radial arteries after percutaneous coronary intervention. The main questions aims to answer: - What is the hemostatic effect of the quantitative pressure hemostatic device after percutaneous coronary intervention? - What are the precise hemostasis pressure and hemostasis time of the radial artery after percutaneous coronary intervention? Participants will be randomly assigned to the intervention group (IG) and control group (CG). The IG will use quantitative pressure patent hemostasis, which will be subdivided into three groups: low pressure group, medium pressure group and high pressure group. The CG will use the conventional radial artery hemostatic device without pressure monitoring. The primary outcomes are hemostasis success and incidence of radial artery occlusion. Secondary outcomes include time to hemostasis, rate of bleeding, hematoma, pain, hand swelling, pseudoaneurysm, antebrachial osteofascial compartment syndrome and oxygen saturation of the compressed side thumb.
The objective of this clinical trial is to compare the hemostatic effect of 2 hemostatic devices with or without quantitative pressure on radial arteries after percutaneous coronary intervention. The main questions aims to answer: - What is the hemostatic effect of the quantitative pressure hemostatic device after percutaneous coronary intervention? - What are the precise hemostasis pressure and hemostasis time of the radial artery after percutaneous coronary intervention? Participants will be randomly assigned to the intervention group (IG) and control group (CG). The IG will use quantitative pressure patent hemostasis, which will be subdivided into three groups: low pressure group, medium pressure group and high pressure group. The IG will use a compression pressure of 120% ,125% or 130% of preoperative upper limb systolic blood pressure after PCI for low, medium, or high pressure group . For the participants assigned to the IG, we will use the quantitative pressure patent hemostasis after the percutaneous coronary intervention. After that, the hemostasis pressure is reduced in a certain gradient every hour until the hemostasis is successful. For the participants assigned to the CG, we will use the hemostatic device (traditionally used in Peking University First Hospital) after percutaneous coronary intervention, and then release the tourniquet hourly based on traditional experience to reduce the hemostatic pressure until the hemostasis is successful. For all enrolled participants, we should record the complications such as bleeding, hematoma, pain, oxygen saturation of compressed thumb and hand swelling in the patient immediately and hourly after the operation. Radial artery occlusion and radial artery thrombosis were confirmed by arterial ultrasound at 24 hours (ward) and postoperative day 30 (follow-up clinic). ;
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