NCT02895009

Hemostatic Compression Patterns After Transradial Coronary Intervention

A Randomized Comparison of TR Band Hemostatic Compression Patterns After Transradial Coronary Intervention

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2016-09-09
• Last updated: 2016-09-21