NCT02398305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

December 4, 2014

Last Update Submit

March 24, 2015

Conditions

Cardiac Catheterisation

Keywords

Cardiac catheterisationRadial accessCompressionTerumo TR Bandradial arterydiagnostic

Outcome Measures

Primary Outcomes (1)

  • Bleeding

    Bleeding at puncture site after deflating pressure in TR band

    1 year

Secondary Outcomes (3)

  • Swelling

    1 year

  • Patient comfort

    1 year

  • Time to discharge, after return on nursing unit

    1 year

Study Arms (2)

TR Band accelerated

ACTIVE COMPARATOR

Diminishing air pressure in the TR Band using accelerated protocol

Device: TR Band Quick

TR band standard

OTHER

Diminishing air pressure in the TR band according to standard care

Device: TR Band standard

Interventions

TR Band standardDEVICE

Diminishing the air pressure in the TR Band following standard protocol

TR band standard
TR Band QuickDEVICE

Diminishing the air pressure in the TR Band following a faster protocol

TR Band accelerated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic coronary angiogram
  • Radial access
  • French sheath

You may not qualify if:

  • Use of oral anticoagulants
  • Percutaneous coronary intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pim van der Harst, MD PhD

    University Medical Center Groningen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MANP

Study Record Dates

First Submitted

December 4, 2014

First Posted

March 25, 2015

Study Start

October 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

NL(1)