At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Caring for the Radial Artery Post-angiogram: A Pilot Study on a Comparison of Three Methods of Compression
In Brief
A clinical study evaluating Terumo TR wristband and Clo-Sur-P.A.D. for Transradial Angiogram. Completed, enrolled 75 participants.
Detailed 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.
Study Details
Timeline
Interventions
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.
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 balloon deflation of 3cc of air occurred 15 minutes after initial inflation. Deflations occurred every 15 minutes unless bleeding was noted. If active bleeding was noted, the balloon was re-inflated (1-3cc) until bleeding stopped. The next deflation occurred 15 minutes later. If no bleeding occurred, deflations continued every 15 minutes until the balloon was completely deflated. The band was removed 15 minutes after final deflation.
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.