Hemostatic Compression Patterns After Transradial Coronary Intervention

Not Applicable

• Conditions: Coronary Disease
• Interventions: Device: experimental group; Device: control group

• Registration Number: NCT02895009
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-09
• Study First Submitted: 2016-09-04
• Study First Submitted QC: 2016-09-04
• Study First Posted: 2016-09-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21
• Primary Completion: 2017-01
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	experimental group	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.
control group	control group	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.

Primary Outcome Measures

Name	Time	Method
RAO incidence	at the 24th hour post TRI	At the 24th hour post TRI, RAO will be diagnosed via ultrasonic sound and RAO incidence will be evaluated between two groups.

Secondary Outcome Measures

Name	Time	Method
patient comfort level	at the 24th hour post TRI	At the 24th hour post TRI, patient comfort level will be evaluated by patients via a visual analogue scale for comfort level.
postoperative puncture site bleeding incidence	within 24 hours after TRI	postoperative puncture site bleeding incidence will be studied in patient between two groups within 24 hours after TRI.