The Study for Evaluate of Satety and Dfficacy of Hemostatic Device

NCT ID: NCT06590571

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-14
• Study Completion Date: 2021-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

TRAcelet™ compression group

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.

Group Type: EXPERIMENTAL

TRAcelet™

Intervention Type: DEVICE

The group using TRAcelet™ after transradial angiography/intervention receives 2 hours and 15 minutes of compression from the device, followed by 3 stepwise releases every 15 minutes. There are two sizes of TRAcelet™ available, large and medium. Assuming that a Korean adult's wrist size is smaller than that of the Western population, we used a medium-sized TRAcelet™.

Conventional compression group

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.

Group Type: OTHER

Gauze pad

Intervention Type: OTHER

Patients received radial artery compression by a gauze pad fastened with 3M™ Durapore™ surgical tape. An additional one hour of compression was applied when incomplete hemostasis or hematoma was identified.

Interventions

TRAcelet™

The group using TRAcelet™ after transradial angiography/intervention receives 2 hours and 15 minutes of compression from the device, followed by 3 stepwise releases every 15 minutes. There are two sizes of TRAcelet™ available, large and medium. Assuming that a Korean adult's wrist size is smaller than that of the Western population, we used a medium-sized TRAcelet™.

Intervention Type: DEVICE

Gauze pad

Patients received radial artery compression by a gauze pad fastened with 3M™ Durapore™ surgical tape. An additional one hour of compression was applied when incomplete hemostasis or hematoma was identified.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Min Ku Chon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pusan National University Yangsan Hospital

Yangsan, Gyeongsannam-do, South Korea

Countries

South Korea

Other Identifiers

TRAcelet study

Identifier Type: -

Identifier Source: org_study_id