Hemostatic Compression Patterns After Transradial Coronary Intervention

Coronary Disease Clinical Trial

— HCPATRI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02895009
• Other study ID #: 2016yzdh19
• Status: Not yet recruiting
• Phase: N/A
• First received: September 4, 2016
• Last updated: September 20, 2016
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2016
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jingwen Hu, Master
• Phone: 008618991232872
• Email: jingwenhu[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

References & Publications (7)

Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. — View Citation

Cong X, Huang Z, Wu J, Wang J, Wen F, Fang L, Fan M, Liang C. Randomized Comparison of 3 Hemostasis Techniques After Transradial Coronary Intervention. J Cardiovasc Nurs. 2016 Sep-Oct;31(5):445-51. doi: 10.1097/JCN.0000000000000268. — View Citation

Dai N, Xu DC, Hou L, Peng WH, Wei YD, Xu YW. A comparison of 2 devices for radial artery hemostasis after transradial coronary intervention. J Cardiovasc Nurs. 2015 May-Jun;30(3):192-6. doi: 10.1097/JCN.0000000000000115. — View Citation

Fech JC, Welsh R, Hegadoren K, Norris CM. Caring for the radial artery post-angiogram: a pilot study on a comparison of three methods of compression. Eur J Cardiovasc Nurs. 2012 Mar;11(1):44-50. doi: 10.1177/1474515111429656. Epub 2012 Jan 11. — View Citation

Kiemeneij F, Laarman GJ. Percutaneous transradial artery approach for coronary stent implantation. Cathet Cardiovasc Diagn. 1993 Oct;30(2):173-8. Erratum in: Cathet Cardiovasc Diagn 1993 Dec;30(4):358. — View Citation

Pancholy SB, Patel TM. Effect of duration of hemostatic compression on radial artery occlusion after transradial access. Catheter Cardiovasc Interv. 2012 Jan 1;79(1):78-81. doi: 10.1002/ccd.22963. Epub 2011 May 16. — View Citation

Rathore S, Stables RH, Pauriah M, Hakeem A, Mills JD, Palmer ND, Perry RA, Morris JL. A randomized comparison of TR band and radistop hemostatic compression devices after transradial coronary intervention. Catheter Cardiovasc Interv. 2010 Nov 1;76(5):660-7. doi: 10.1002/ccd.22615. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RAO incidence	At the 24th hour post TRI, RAO will be diagnosed via ultrasonic sound and RAO incidence will be evaluated between two groups.	at the 24th hour post TRI	No
Secondary	postoperative puncture site bleeding incidence	postoperative puncture site bleeding incidence will be studied in patient between two groups within 24 hours after TRI.	within 24 hours after TRI	No
Secondary	patient comfort level	At the 24th hour post TRI, patient comfort level will be evaluated by patients via a visual analogue scale for comfort level.	at the 24th hour post TRI	No