The Study for Evaluate of Satety and Dfficacy of Hemostatic Device

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: TRAcelet™; Other: Gauze pad

• Registration Number: NCT06590571
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

The goal of this clinical trial is to compare the new pneumatic compression device TRAcelet with conventional compression method in patients undergone transradial coronary angiography. The main question it aims to answer is the achievement of successful hemostasis at 3 hours.

Researchers will compare conventional compression to see if new pneumatic device can provide better hemostasis.

Detailed Description

Although there are several devices available for radial artery hemostasis, conventional compression with a gauze pad is thought to be the easiest method. One of the devices with a pneumatic compression balloon is the TRAcelet™, and there is not much research comparing the device and conventional compression method. Therefore, the investigators aimed to compare the pneumatic compression device TRAcelet with the conventional compression method in patients who underwent transradial coronary angiography/intervention.

The primary endpoint was the achievement of successful hemostasis at 3 hours. Successful hemostasis was defined as the absence of oozing and the absence of hematoma formation after the device was released. If incomplete hemostasis was observed after 3 hours, the achievement of hemostasis after an additional hour of compression was also considered successful. Conversely, if hemostasis could not be established, it was defined as unsuccessful hemostasis. The secondary endpoints included the total banding time, local vascular complications classified according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) scale, pain or discomfort related to the transradial approach, which was assessed by the participants using the Wong-Baker Faces Pain Rating Scale and numeric pain rating scale, and the RAO at one month.

Study Timeline

• Study Start: 2018-12-14
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2024-08-16
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

• aged over 20 years
• Underwent coronary angiography under suspicion of coronary artery disease
• Agreed to participate in the trial before the coronary angiography procedure

Exclusion Criteria

• Bleeding tendency due to congenital or acquired disorders such as severe liver disease, thrombocytopenia (platelet count below 50,000 cells/μL)
• Those who were on anticoagulants.
• Patients who could not provide voluntary consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRAcelet™ compression group	TRAcelet™	the group using TRAcelet™ received 2 hours and 15 minutes of compression from the device with 13 cc of air being blown in, followed by 3 stepwise releases every 15 minutes through counterclockwise rotation of the dial without extracting air using a syringe. This achieved the same 3 hours of compression. The dial started at the triangle position and was set to nine, six, and three at every stepwise decompression. After three hours, the device was released.
Conventional compression group	Gauze pad	Patients who were assigned to the conventional group received radial artery compression by a gauze pad folded into a cuboid shape, fastened with 3M™ Durapore™ surgical tape. The gauze pad was not impregnated with prothrombotic material. Compression was released at 3 hours to check for complications. An additional one hour of compression was applied when incomplete hemostasis or hematoma was identified.

Primary Outcome Measures

Name	Time	Method
The achievement of successful hemostasis at 3 hours.	3 hours after the procedure	Successful hemostasis was defined as the absence of oozing and the absence of hematoma formation after the device was released. If incomplete hemostasis was observed after 3 hours, the achievement of hemostasis after an additional hour of compression was also considered successful.

Secondary Outcome Measures

Name	Time	Method
total hemostasis time	4 hours after the procedure	Total banding time
complication of procedures	4 hours after the procedure	Pain assessment :Wong-Baker Facial Grimace Scale(The Wong-Baker Facial Grimace Scale is a tool used to assess pain in patients who may have difficulty verbalizing their pain, such as children or individuals with cognitive impairments. It involves a series of facial expressions that represent varying levels of pain)

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongsannam-do, Korea, Republic of