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Completed

NCT Number: NCT01326455

Caring for the Radial Artery Post-angiogram

The purpose of this pilot study was to compare two devices and three methods for achieving hemostasis after a transradial angiogram while assessing vascular complications and time endpoints. The heart has traditionally been accessed through the femoral artery. However, in the last 20 years, the radial artery has gained more popularity among physicians and patients, thereby offering an alternative to the femoral approach. Various methods of applying compression to the radial puncture site have been used, but no research has been done to show what best practice is. In this case, best practice would be the most effective way of getting hemostasis while limiting complications and ensuring the efficient use of nursing and medical resources. It is hypothesized that statistically significant differences are seen in time to discharge in the fast-release Terumo and Clo-Sur P.A.D. groups, as compared with the control Terumo group, without increasing vascular complications.

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Key information

Conditions

Transradial Angiogram

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • nonemergent
  • outpatient

Exclusion criteria

  • inpatients
  • emergency patients
  • booked angioplasty patients
  • cognitive impairment
  • those in whom the approach was initiated but aborted due to inability to puncture the radial artery

Treatment and study plan

Terumo TR wristband

Device

A transparent unilateral compression device which is secured to the wrist via strap with velcro. The portion with the deflated 18cc balloon is placed directly over the puncture site. This balloon is inflated immediately after the catheter is removed and the balloon is inflated until bleeding visibly stops, with generally 9-18cc of air.

First deflation of 3cc of air occurred 1 hour after inflation. Deflations occurred every 15 minutes unless bleeding was noted. If bleeding was noted, balloon was reinflated (1-3cc of air) until bleeding stopped. Next deflation occurred 30 minutes later, at which point regular 15 minutes deflations occurred if no bleeding noted. Band was removed 1 hour after final deflation.

Clo-Sur-P.A.D.

Device

A hydrophilic dressing has a high affinity for water, and absorbs and controls body fluid. The positively charged 4x4 centimetre pad reacts with the neuraminic acid residue on red blood cells causing agglutination of the cells. The Clo-Sur P.A.D. works outside of the clotting cascade.

The radial catheter was removed and occlusive pressure applied on the radial artery. Pressure was released just until bleeding noted & the pad was applied with approximately 5 minutes of manual compression. The pad was assessed every 15 minutes for 90 minutes to ensure hemostasis. The pad was removed on post-CATH day 1.

Primary outcomes

  1. Bleeding Requiring Intervention After Initial Hemostasis Achieved

    Time frame: Assessed after initial hemostasis achieved

    Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved

  2. Bleeding Requiring Intervention Post-CATH Day 1

    Time frame: Assessed post-CATH Day 1

    Number of Participants with Bleeding Requiring Intervention post-CATH Day 1

Secondary outcomes

  1. Time to Discharge

    Time frame: Assessed on day of angiogram.

    Time to discharge in minutes.

  2. Hematoma or Bruising at Discharge

    Time frame: Assessed at discharge

    Number of Participants with hematoma or bruising at discharge

  3. Hematoma or Bruising Post-CATH Day 1

    Time frame: Assessed post-CATH day 1.

    Number of Participants with hematoma or bruising post-CATH Day 1

  4. Radial Artery Occlusion Post-CATH

    Time frame: Assessed via plethysmography and palpation post-CATH

    Number of Participants with Radial Artery Occlusion post-CATH

  5. Radial Artery Occlusion Post-CATH Day 1

    Time frame: Assessed via plethysmography and palpation post-CATH day 1.

    Number of Participants with Radial Artery Occlusion post-CATH Day 1

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Caring for the Radial Artery Post-angiogram: A Pilot Study on a Comparison of Three Methods of Compression

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2011
Registry last updated
Sep 28, 2022

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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