The Study for Evaluate of Satety and Dfficacy of Hemostatic Device

Pusan National University Yangsan Hospital

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Other: Gauze pad; Device: TRAcelet™

Study type: Interventional

Funder types: Other

Identifiers

NCT06590571

TRAcelet study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 227 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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227 participants in 2 patient groups

TRAcelet™ compression group

Experimental group

Description:

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.

Treatment:

Device: TRAcelet™

Conventional compression group

Other group

Description:

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.

Treatment:

Other: Gauze pad