Hemostatic Compression Patterns After Transradial Coronary Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type OTHER

control group

Intervention Type DEVICE

Participants allocated to the control group will receive a routine long term postoperative puncture site compression via TR Band. TR Band deflation is commenced at the 2nd hour and completed at the 6th hour, and the TR Band is removed at the 24th hour.

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.

Group Type EXPERIMENTAL

experimental group

Intervention Type DEVICE

Participants allocated to the experimental group will receive a short term postoperative puncture site compression via TR Band. TR Band deflation is commenced at the 1st hour and completed at the 3rd hour, and the TR Band is removed at the 12th hour.

Interventions

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experimental group

Participants allocated to the experimental group will receive a short term postoperative puncture site compression via TR Band. TR Band deflation is commenced at the 1st hour and completed at the 3rd hour, and the TR Band is removed at the 12th hour.

Intervention Type DEVICE

control group

Participants allocated to the control group will receive a routine long term postoperative puncture site compression via TR Band. TR Band deflation is commenced at the 2nd hour and completed at the 6th hour, and the TR Band is removed at the 24th hour.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No