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

Percutaneous Coronary Intervention Clinical Trial

— PCI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05790603
• Other study ID #: 2023SF05
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Peking University First Hospital
• Contact: Zhenhui Tao
• Phone: +8613811839842
• Email: terry1018china[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemostasis
• Percutaneous Coronary Intervention

Intervention

Device:
• Experimental: Low pressure group of quantitative pressure patent hemostasis
The compression pressure was 120% of upper SBP. Pressure will be released by 4% hourly until the bleeding is stopped.
• Experimental: Medium pressure group of quantitative pressure patent hemostasis
The compression pressure was 125% of upper SBP. Pressure will be released by 5% hourly until the bleeding is stopped.
• Experimental: High pressure group of quantitative pressure patent hemostasis
The compression pressure was 130% of upper SBP. Pressure will be released by 5% hourly until the bleeding is stopped.
• Active Comparator: Conventional radial artery hemostat device
Radial artery hemostatic device. Pressure will be released hourly based on medical staff's experiences until the bleeding is stopped.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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 Cardi — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence early radial artery occlusion	RAO occurs within 24 hours after PCI	Within 24 hours after PCI
Primary	Incidence of access site bleeding	A hematoma formation requiring or not requiring specific therapy	Within 24 hours after PCI
Secondary	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
Secondary	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
Secondary	Acute artery thrombus	Radial artery thrombus occurs but not radial artery occlusion	Within 24 hours after PCI
Secondary	Hemoglobin	value of hemoglobin	baseline; 24 hours after PCI
Secondary	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
Secondary	Hand swelling	The circumference diameter of both hands was measured using a tape gauge contrast.	baseline; 24 hours after PCI
Secondary	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