Effect of Hemostatic Device With Quantitative Pressure on Radial Artery Hemostasis After PCI

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effect of Hemostatic Device With Quantitative Pressure on Radial Artery Hemostasis After Percutaneous Coronary Intervention：a Randomized Controlled Trial

Conditions
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Hemostasis, Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Experimental: Low pressure group of quantitative pressure patent hemostasis
* Device: Experimental: Medium pressure group of quantitative pressure patent hemostasis
* Device: Experimental: High pressure group of quantitative pressure patent hemostasis
* Device: Active Comparator: Conventional radial artery hemostat device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Allen positive; Receiving radial coronary angiography or coronary intervention; Being conscious. Exclusion Criteria: The radial puncture fail the first time; Coagulopathy; Diagnosis of chronic kidney disease or cirrhosis; Radial artery malformation; Being treated with IIb / IIIa receptor antagonist.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low pressure group<br>This group will use the radial artery hemostatic device with quantitative pressure which will be the new patent product made by Shandong Weigao Group Medical Polymer Products Co. LTD,China. The compression pressure on radial artery after PCI was 120% of upper arm systolic BP measured preoperatively. Pressure will be released by 4% hourly until the bleeding is stopped. | Device: Experimental: Low pressure group of quantitative pressure patent hemostasis<br>* The compression pressure was 120% of upper SBP. Pressure will be released by 4% hourly until the bleeding is stopped.<br>|
| Experimental: Medium pressure group<br>This group will use the radial artery hemostatic device with quantitative pressure which will be the new patent product made by Shandong Weigao Group Medical Polymer Products Co. LTD,China. The compression pressure on radial artery after PCI was 125% of upper arm systolic BP measured preoperatively. Pressure will be released by 5% hourly until the bleeding is stopped. | Device: Experimental: Medium pressure group of quantitative pressure patent hemostasis<br>* The compression pressure was 125% of upper SBP. Pressure will be released by 5% hourly until the bleeding is stopped.<br>|
| Experimental: High pressure group<br>This group will use the radial artery hemostatic device with quantitative pressure which will be the new patent product made by Shandong Weigao Group Medical Polymer Products Co. LTD,China. The compression pressure on radial artery after PCI was 130% of upper arm systolic BP measured preoperatively. Pressure will be released by 6% hourly until the bleeding is stopped. | Device: Experimental: High pressure group of quantitative pressure patent hemostasis<br>* The compression pressure was 130% of upper SBP. Pressure will be released by 5% hourly until the bleeding is stopped.<br>|
| Active Comparator: Control group<br>The control group will use the radial artery hemostatic device named by Radial Pressure Hemostat made by Rayon Medical Corporation,Japan (hemostatic device traditionally used in Peking University First Hospital). Pressure will be released hourly based on medical staff's experiences until the bleeding is stopped. | Device: Active Comparator: Conventional radial artery hemostat device<br>* Radial artery hemostatic device. Pressure will be released hourly based on medical staff's experiences until the bleeding is stopped.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence early radial artery occlusion | RAO occurs within 24 hours after PCI | Within 24 hours after PCI | 
| Incidence of access site bleeding | A hematoma formation requiring or not requiring specific therapy | Within 24 hours after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compression time | The interval from the time of sheath removal to the time of hemostasis removal | through hemostasis completion，estimated to be an average of 4 6hours | 
| Incidence of hematoma | The incidence of subcutaneous hematoma in the distal skin of the compression site 24 h after the removal of the compression device | through hemostasis completion，estimated to be an average of 4 6hours | 
| Acute artery thrombus | Radial artery thrombus occurs but not radial artery occlusion | Within 24 hours after PCI | 
| Hemoglobin | value of hemoglobin | baseline; 24 hours after PCI | 
| The degree of pain | Pain level is classified as painless: 0; mild pain: 1 3; moderate pain: 4 6; severe pain: 7 10. | baseline; 24 hours after PCI | 
| Hand swelling | The circumference diameter of both hands was measured using a tape gauge contrast. | baseline; 24 hours after PCI | 
| False aneurysm | It refers to the lumen of the same as the artery formed by the blood through the perivascular tissue after arterial puncture. | Within 24 hours after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Radial artery hemostasis, Quantitative pressure, Randomized controlled trial