Hemostatic Compression Patterns After Transradial Coronary Intervention
HCPATRI
A Randomized Comparison of TR Band Hemostatic Compression Patterns After Transradial Coronary Intervention
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 4, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedSeptember 21, 2016
August 1, 2016
4 months
September 4, 2016
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
postoperative puncture site bleeding incidence
within 24 hours after TRI
patient comfort level
at the 24th hour post TRI
Study Arms (2)
control group
OTHERParticipants 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.
experimental group
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients 18 years or older
- Patients who received TRI for the first time
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. doi: 10.1002/ccd.1810160103.
PMID: 2912567BACKGROUNDKiemeneij F, Laarman GJ. Percutaneous transradial artery approach for coronary stent implantation. Cathet Cardiovasc Diagn. 1993 Oct;30(2):173-8. doi: 10.1002/ccd.1810300220.
PMID: 8221875BACKGROUNDRathore 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.
PMID: 20506228BACKGROUNDDai 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.
PMID: 24496325BACKGROUNDCong 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.
PMID: 26002786BACKGROUNDFech 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.
PMID: 22357780BACKGROUNDPancholy 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.
PMID: 21584923BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jingwen Hu, Master
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2016
First Posted
September 9, 2016
Study Start
September 1, 2016
Primary Completion
January 1, 2017
Study Completion
March 1, 2017
Last Updated
September 21, 2016
Record last verified: 2016-08