Hemostatic Compression Patterns After Transradial Coronary Intervention (HCPATRI)

Xi'an Jiaotong University

Status: Unknown

Conditions: Coronary Disease

Treatments: Device: control group; Device: experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT02895009

2016yzdh19

Details and patient eligibility

About

The purpose of the study is to investigate the protective effects of short term TR Band compression on transradial coronary occlusion after transradial coronary intervention.

Full description

Radial artery occlusion (RAO), an infrequent but serious complication after transradial coronary intervention (TRI), prevents subsequent use of the same radial artery for coronary angiography and intervention. Comparing to the overseas counterparts, most Chinese medical workers put more emphasis on prevention of postoperative puncture site bleeding, so longer compression hemostasis time is applied but this prolonged compression may underestimate or even ignore an increasing risk of RAO. Therefore, this study intends to compare short term TR Band compression and the routine long term one on transradial coronary occlusion after transradial coronary intervention.

Participants allocated to the control group will receive a routine long term postoperative puncture site compression via TR Band. In control group, TR Band deflation is commenced at the 2nd hour with successive 5 mL air released at 2 hours intervals until the bladder was empty at the 6th hour, and the TR Band is removed at the 24th hour.

Participants allocated to the experimental group will receive a short term postoperative puncture site compression via TR Band. In experimental group, TR Band deflation is commenced at the 1st hour with 3 mL air released, and at the 2nd hour with 5ml, and at the 3rd hour with the remainder air in the bladder, and the TR Band is removed at the 12th hour.

At the 24th hour, RAO incidence, postoperative puncture site bleeding incidence and patient comfort level will be evaluated.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years or older
• Patients who received TRI for the first time

Exclusion criteria

• Failure to puncture the radial artery in 1 attempt
• Inaccessible radial arteries because of anatomic variations, such as hypoplastic radial arteries and radioulnar loop, which can be confirmed by radial artery angiography before the TRI
• Patients who had previous radial procedure
• Patients who were receiving IIb/IIIa receptor antagonist treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

control group

Other group

Description:

Participants allocated to the control group will receive a routine long term postoperative puncture site compression via TR Band. In control group, TR Band deflation is commenced at the 2nd hour with successive 5 mL air released at 2 hours intervals until the bladder was empty at the 6th hour, and the TR Band is removed at the 24th hour.

Treatment:

Device: control group

experimental group

Experimental group

Description:

Participants allocated to the experimental group will receive a short term postoperative puncture site compression via TR Band. In experimental group, TR Band deflation is commenced at the 1st hour with 3 mL air released, and at the 2nd hour with 5ml, and at the 3rd hour with the remainder air in the bladder, and the TR Band is removed at the 12th hour.

Treatment:

Device: experimental group