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OpenTrials
Completed

NCT Number: NCT02398305

Shortening Compression Time After Radial Access for Cardiac Catheterisation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnostic coronary angiogram
  • Radial access
  • 6 French sheath

Exclusion criteria

  • Use of oral anticoagulants
  • Percutaneous coronary intervention

Treatment and study plan

TR Band standard

Device

Diminishing the air pressure in the TR Band following standard protocol

TR Band Quick

Device

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

Primary outcomes

  1. Bleeding

    Time frame: 1 year

    Bleeding at puncture site after deflating pressure in TR band

Secondary outcomes

  1. Swelling

    Time frame: 1 year

    Swelling at puncture site that is not caused by bleeding

  2. Patient comfort

    Time frame: 1 year

    Patient comfort, measured on VAS

  3. Time to discharge, after return on nursing unit

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2015
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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