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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terumo Control | Other |
| |
| Terumo Fast Release | Active Comparator |
| |
| Clo-Sur P.A.D. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge | Time to discharge in minutes. | Assessed on day of angiogram. |
| Hematoma or Bruising at Discharge | Number of Participants with hematoma or bruising at discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen Norris, PhD | University of Alberta | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22357780 | Background | 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. |
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Participants were enrolled prior to the angiogram. Those patients in whom the transradial approach was initiated but aborted due to inability to puncture the radial artery were not included in the study. Enrolled patients were also excluded if the angiogram was performed solely via the femoral artery.
The pilot study was set in one Cardiac Cath Lab and Recovery room. The sample was one of convenience. The goal was for 75 people to participate, 25 per group. The individuals targeted were those having an angiogram done on a non-emergent, outpatient basis. Recruitment took place from May 2009 until March 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Terumo Control | A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation. |
| FG001 | Terumo Fast Release | A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation. |
| FG002 | Clo-Sur P.A.D. | A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Terumo Control | A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation |
| BG001 | Terumo Fast Release |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bleeding Requiring Intervention After Initial Hemostasis Achieved | Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved | Posted | Number | participants | Assessed after initial hemostasis achieved |
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Terumo Control | A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fech | UAlberta | jennifer.fech@albertahealthservices.ca |
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|
| 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 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. |
|
| 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. |
|
| Assessed at discharge |
| Hematoma or Bruising Post-CATH Day 1 | Number of Participants with hematoma or bruising post-CATH Day 1 | Assessed post-CATH day 1. |
| Radial Artery Occlusion Post-CATH | Number of Participants with Radial Artery Occlusion post-CATH | Assessed via plethysmography and palpation post-CATH |
| Radial Artery Occlusion Post-CATH Day 1 | Number of Participants with Radial Artery Occlusion post-CATH Day 1 | Assessed via plethysmography and palpation post-CATH day 1. |
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation.
| BG002 | Clo-Sur P.A.D. | A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1 |
| BG003 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Clo-Sur P.A.D. |
A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1 |
|
|
|
| Primary | Bleeding Requiring Intervention Post-CATH Day 1 | Number of Participants with Bleeding Requiring Intervention post-CATH Day 1 | Lancaster et. al. (2004) quoted the number 30 as a general sample size for a pilot study. Each arm of this study had 25 people (due to time constraints), giving a total of 75 people. The data were analyzed using t-tests for equality of means, a two-way analysis of variance (ANOVA), and chi-square. Significance was set at p < 0.05. | Posted | Number | participants | Assessed post-CATH Day 1 |
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| Secondary | Time to Discharge | Time to discharge in minutes. | Posted | Mean | Standard Deviation | minutes | Assessed on day of angiogram. |
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| Secondary | Hematoma or Bruising at Discharge | Number of Participants with hematoma or bruising at discharge | Posted | Number | participants | Assessed at discharge |
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| Secondary | Hematoma or Bruising Post-CATH Day 1 | Number of Participants with hematoma or bruising post-CATH Day 1 | Posted | Number | participants | Assessed post-CATH day 1. |
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| Secondary | Radial Artery Occlusion Post-CATH | Number of Participants with Radial Artery Occlusion post-CATH | Posted | Number | participants | Assessed via plethysmography and palpation post-CATH |
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| Secondary | Radial Artery Occlusion Post-CATH Day 1 | Number of Participants with Radial Artery Occlusion post-CATH Day 1 | Posted | Number | participants | Assessed via plethysmography and palpation post-CATH day 1. |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Terumo Fast Release | A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Clo-Sur P.A.D. | A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1 | 0 | 25 | 0 | 25 | 0 | 25 |
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| Superiority or Other (legacy) |
| ANOVA | 0.144 | Superiority or Other (legacy) |