Coronary Disease
Conditions
Keywords
Coronary Disease, Radial artery occlusion, transradial coronary intervention
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.
Interventions
DEVICEexperimental 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.
DEVICEcontrol 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.
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Contacts
Primary ContactJingwen Hu, Master
Outcome results
None listed