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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
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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 coronary angiography (CAG) or percutaneous coronary intervention (PCI). The main questions aims to answer:
The primary outcomes is incidence of 24h radial artery occlusion (24h RAO). Secondary outcomes include time to hemostasis, bleeding, hematoma, 30d radial artery occlusion (30d RAO), pain, hand swelling, numberness, pseudoaneurysm, and radial artery stenosis.
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:
Participants will be randomly assigned to the intervention group (IG) and control group (CG).
For the participants assigned to the IG, the radial systolic pressure will be measured after TRA procedure. The PHD-Band with quantitative pressure ( WEGO Medical Products Group CO. LTD, China) will be placed at the entry site of the sheath. Connecting the hemostatic devices to the electric pneumatic machine with a connecting cable. After removing the radial sheath, the puncture site will be compressed by operator's hand. The PHD-Band with quantitative pressure will be inflated with specific pressure radial systolic pressure plus 10mmHg) and the hand will slowly release the pressure. If bleeding occurs, the PHD-Band will be deflated with 5-10mmHg automatically by parameter setting with the electric pneumatic machine until the bleeding stops. The PHD-Band will be deflated with20 mmHg, 40 mmHg of decreased pressure following 1h and 2h after the procedure. After 3 hours, the hemostatic pressure will be released to 45mmHg and the PHD-Band will be removed if no bleeding occurs. If rebleeding occurs, the band will be inflated according to the previous pressure for another an hour until bleeding stops.
For the participants assigned to the CG, the TR-Band (Terumo Medical Corporation, Japan) will be placed at the entry site of the sheath after TRA procedure and inflated with 10 mL of air and the radial sheath will be removed with hand compression. Another 5 mL of air will be inflated and the operator's hand will slowly release the pressure. The TR band will be inflated until bleeding stopped with the maximum air volume no more than 18ml. The band will be deflated with 1 mL of air hourly for the following 2 hours after the procedure. After 3 hours, the band will be deflated with 4 mL of air first and then all volume of the rest air if no bleeding occurs and then the band will be removed if no bleeding occurs. If rebleeding occurs, the band will be inflated with 1 mL of air until bleeding stops .
For all enrolled participants, the investigators will record the complications such as bleeding, subcutaneous hematoma, pain, hand swelling, numbness, pseudoaneurysm after the operation. Radial artery occlusion, subcutaneous hematoma, pseudoaneurysm, and radial artery stenosis were confirmed by arterial ultrasound within 24 hours and 30 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | PHD-band Group |
|
| Control group | Active Comparator | TR-band Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group with PHD-Band | Device | The initial compression pressure was systolic blood pressure plus 10mmHg. Pressure will be released by 20mmHg and 40mmHg 1 hour and 2 hours respectively after the surgery and then the band will be removed after 3 hours if no bleeding occurs. The compression will continue if bleeding occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence early radial artery occlusion | RAO occurs within 24 hours after CAG/PCI | Within 24 hours after CAG/PCI |
| 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 3~6hours |
| Incidence of access site bleeding |
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Inclusion Criteria:
Patients undergoing coronary angiography or percutaneous coronary intervention via the radial artery; Positive Allen's test result; Willing to sign informed consent.
Exclusion Criteria:
Radial artery malformation； Chronic kidney disease with eGFR<30ml/min.1.73m2; Cirrhosis of the liver; Coagulation disfunction; Patients treated with IIb / IIIa receptor antagonist.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenhui Tao | Contact | +8613811839842 | terry1018china@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenhui Tao | Peking University First Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100053 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29880098 | Background | Petroglou D, Didagelos M, Chalikias G, Tziakas D, Tsigkas G, Hahalis G, Koutouzis M, Ntatsios A, Tsiafoutis I, Hamilos M, Kouparanis A, Konstantinidis N, Sofidis G, Pancholy SB, Karvounis H, Bertrand OF, Ziakas A. Manual Versus Mechanical Compression of the Radial Artery After Transradial Coronary Angiography: The MEMORY Multicenter Randomized Trial. JACC Cardiovasc Interv. 2018 Jun 11;11(11):1050-1058. doi: 10.1016/j.jcin.2018.03.042. | |
| 3233513 |
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One of the primary outcome of radial artery occlusion will be assessed by masking the assessor. The data analyzers will also be blinded.
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|
| Control group with TR-Band | Device | TR-Band will be inflated with 15 mL of air The band will be deflated with 1 mL of air hourly for the following 2 hours after the procedure. After 3 hours, the band will be removed if no bleeding occurs. If rebleeding occurs, the band will be inflated with appropriate volume of air until bleeding stops . |
|
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Access site bleeding within 24 hours after CAG/PCI
| Within 24 hours after CAG/PCI |
| 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 |
| Incidence of 30d radial artery occlusion | RAO occurs within 30 days after CAG/PCI | Within 30 days after CAG/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 |
| numbness | Numbness level is classified as no numbness with 0, mild numbness: 1~2; moderate numbness: 3; severe numbness:4~5 | 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 |
| pseudoaneurysm | 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 |
| Peking University First Hospital |
| Recruiting |
| Beijing |
| China |
|
| Background |
| Deitrich-MacLean G, Walden T. Distinguishing teaching interactions of physically abusive from nonabusive parent-child dyads. Child Abuse Negl. 1988;12(4):469-79. doi: 10.1016/0145-2134(88)90064-6. |
| 35694680 | Background | Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022. |
| 35589232 | Result | Eid-Lidt G, Reyes-Carrera J, Farjat-Pasos JI, Saenz AL, Bravo CA, Rangel SN, Salido DZ, Vega Servin NS, Soto-Lopez ME, Gaspar J. Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography. JACC Cardiovasc Interv. 2022 May 23;15(10):1022-1029. doi: 10.1016/j.jcin.2022.03.011. |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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