Shortening Compression Time After Radial Access for Cardiac Catheterisation

Not Applicable

Completed

• Conditions: Cardiac Catheterisation
• Interventions: Device: TR Band Quick; Device: TR Band standard

• Registration Number: NCT02398305
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Study First Submitted: 2014-12-04
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-24
• Last Update Submitted: 2015-03-24
• Study First Posted: 2015-03-25
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• Diagnostic coronary angiogram
• Radial access
• 6 French sheath

Exclusion Criteria

• Use of oral anticoagulants
• Percutaneous coronary intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TR Band accelerated	TR Band Quick	Diminishing air pressure in the TR Band using accelerated protocol
TR band standard	TR Band standard	Diminishing air pressure in the TR band according to standard care

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands