Caring for the Radial Artery Post-angiogram

NCT01326455 | Completed Results

• 1 other identifier: Pro00005016
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Transradial Angiogram

Keywords

transradial; angiogram; device; Care of the radial artery post transradial angiogram

Outcome Measures

Primary Outcomes (2)

• Bleeding Requiring Intervention After Initial Hemostasis Achieved

  Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved

  Assessed after initial hemostasis achieved

• Bleeding Requiring Intervention Post-CATH Day 1

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

  Assessed post-CATH Day 1

Secondary Outcomes (5)

• Time to Discharge

  Assessed on day of angiogram.

• Hematoma or Bruising at Discharge

  Assessed at discharge

• Hematoma or Bruising Post-CATH Day 1

  Assessed post-CATH day 1.

• Radial Artery Occlusion Post-CATH

  Assessed via plethysmography and palpation post-CATH

• Radial Artery Occlusion Post-CATH Day 1

  Assessed via plethysmography and palpation post-CATH day 1.

Study Arms (3)

Terumo Control

OTHER

Device: Terumo TR wristband

Terumo Fast Release

ACTIVE COMPARATOR

Device: Terumo TR wristband

Clo-Sur P.A.D.

ACTIVE COMPARATOR

Device: Clo-Sur-P.A.D.

Interventions

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.

Terumo Control

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.

Clo-Sur P.A.D.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nonemergent
• outpatient

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Related Publications (1)

• Fech JC, Welsh R, Hegadoren K, Norris CM. Caring for the radial artery post-angiogram: a pilot study on a comparison of three methods of compression. Eur J Cardiovasc Nurs. 2012 Mar;11(1):44-50. doi: 10.1177/1474515111429656. Epub 2012 Jan 11.

  PMID: 22357780 BACKGROUND

Limitations and Caveats

This was a pilot study. Not all extraneous variables were previously identified. The trial took place at a single-centre with a select number of cardiologists and nurses.

Results Point of Contact

• Title: Jennifer Fech
• Organization: UAlberta

jennifer.fech@albertahealthservices.ca

Study Officials

• Colleen Norris, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 30, 2011
• Study Start: May 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2011-09