Shortening Compression Time After Radial Access for Cardiac Catheterisation

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: Cardiac Catheterisation
• Intervention / Treatment: Device: TR Band Quick; Device: TR Band standard

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Bleeding at puncture site after deflating pressure in TR band	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Compression; diagnostic; Radial access; radial artery; Cardiac catheterisation; Terumo TR Band
• Other Study ID Numbers: METc2011-233