Hemostatic Compression Patterns After Transradial Coronary Intervention (HCPATRI)

September 20, 2016 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control group
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.
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.
Experimental: experimental group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RAO incidence
Time Frame: 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.
at the 24th hour post TRI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative puncture site bleeding incidence
Time Frame: within 24 hours after TRI
postoperative puncture site bleeding incidence will be studied in patient between two groups within 24 hours after TRI.
within 24 hours after TRI
patient comfort level
Time Frame: 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.
at the 24th hour post TRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Jingwen Hu, Master, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

September 4, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016yzdh19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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