Clinical trial NCT02895009: Hemostatic Compression Patterns After Transradial Coronary Intervention
Official title: A Randomized Comparison of TR Band Hemostatic Compression Patterns After Transradial Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Disease
Keywords: Coronary Disease
Radial artery occlusion
transradial coronary intervention
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: RAO incidence
timeFrame: at the 24th hour post TRI
Secondary outcomes:
measure: postoperative puncture site bleeding incidence
timeFrame: within 24 hours after TRI
measure: patient comfort level
timeFrame: at the 24th hour post TRI
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Jingwen Hu, Master
role: PRINCIPAL_INVESTIGATOR
References:
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