Shortening Compression Time After Radial Access for Cardiac Catheterisation

March 24, 2015 updated by: J.H.H. (Han) Deuling, University Medical Center Groningen

Shortening Compression Time of the Access Site After Cardiac Catheterisation Through the Radial Artery

To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary intervention (PCI) the cardiologist can choose between the femoral artery and the radial artery. In the University Medical Center Groningen the femoral artery is commonly used. After intervention the puncture site is closed with an arteriotomy closure device (ACD). Patients after radial access receive a pressure bandage at the puncture site, usually the Terumo (TR) wrist bandage.

The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1 hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding complications after the procedure. In patients with radial access, the TR bandage will be removed according to current protocol after 4 hours and additionally 1 hour observation is required. Several cardiologists have the intention to use the radial artery more frequent for cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73% decrease in major bleeding complications compared to femoral access. Also there are no significant differences in MACE. Even so there are no differences in success percentage for cardiac catheterization or PCI and admission time is shorter for radial access (Am Heart J. 2009 Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the short-stay unit is in case of femoral access with an ACD approximately 2 hours. For patients after radial access post procedural admission time is approximately 5 hours. To guarantee patient throughput, uniformity of care and more efficient use of capacity of the short-stay unit, patients after radial access should not have a longer hospital admission time than patients after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown that it is safe to deflate the TR wrist band faster than four hours.

Objective of the study:

To describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

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 Locations

  • Netherlands
      • Groningen, Netherlands, 9713GZ
        • University Medical Centre Groningen

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic coronary angiogram
  • Radial access
  • 6 French sheath

Exclusion Criteria:

  • Use of oral anticoagulants
  • Percutaneous coronary intervention

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TR Band accelerated
Diminishing air pressure in the TR Band using accelerated protocol
Device: TR Band Quick
Diminishing the air pressure in the TR Band following a faster protocol
Other: TR band standard
Diminishing air pressure in the TR band according to standard care
Device: TR Band standard
Diminishing the air pressure in the TR Band following standard protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: 1 year
Bleeding at puncture site after deflating pressure in TR band
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swelling
Time Frame: 1 year
Swelling at puncture site that is not caused by bleeding
1 year
Patient comfort
Time Frame: 1 year
Patient comfort, measured on VAS
1 year
Time to discharge, after return on nursing unit
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Investigators

  • Study Director: Pim van der Harst, MD PhD, University Medical Center Groningen

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

October 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • METc2011-233

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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