Transradial Angiogram
Conditions
Keywords
transradial, angiogram, device, Care of the radial artery post transradial angiogram
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.
Interventions
DEVICETerumo TR wristband
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.
DEVICEClo-Sur-P.A.D.
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.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Requiring Intervention After Initial Hemostasis Achieved | Assessed after initial hemostasis achieved | Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved |
| Bleeding Requiring Intervention Post-CATH Day 1 | Assessed post-CATH Day 1 | Number of Participants with Bleeding Requiring Intervention post-CATH Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma or Bruising Post-CATH Day 1 | Assessed post-CATH day 1. | Number of Participants with hematoma or bruising post-CATH Day 1 |
| Time to Discharge | Assessed on day of angiogram. | Time to discharge in minutes. |
| Radial Artery Occlusion Post-CATH Day 1 | Assessed via plethysmography and palpation post-CATH day 1. | Number of Participants with Radial Artery Occlusion post-CATH Day 1 |
| Radial Artery Occlusion Post-CATH | Assessed via plethysmography and palpation post-CATH | Number of Participants with Radial Artery Occlusion post-CATH |
| Hematoma or Bruising at Discharge | Assessed at discharge | Number of Participants with hematoma or bruising at discharge |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Terumo Control A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation | 25 |
| Terumo Fast Release A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation. | 25 |
| 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 | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | Terumo Control | Terumo Fast Release | Clo-Sur P.A.D. | Total |
|---|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 11.2 | 62.1 years STANDARD_DEVIATION 8.3 | 64.1 years STANDARD_DEVIATION 10.6 | 63.2 years STANDARD_DEVIATION 10 |
| Age, Customized >=18 years | 25 participants | 25 participants | 25 participants | 75 participants |
| Region of Enrollment Canada | 25 participants | 25 participants | 25 participants | 75 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 22 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Bleeding Requiring Intervention After Initial Hemostasis Achieved
Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved
Time frame: Assessed after initial hemostasis achieved
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terumo Control | Bleeding Requiring Intervention After Initial Hemostasis Achieved | 2 participants |
| Terumo Fast Release | Bleeding Requiring Intervention After Initial Hemostasis Achieved | 6 participants |
| Clo-Sur P.A.D. | Bleeding Requiring Intervention After Initial Hemostasis Achieved | 3 participants |
Comparison: 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.p-value: 0.25Chi-squared
Primary
Bleeding Requiring Intervention Post-CATH Day 1
Number of Participants with Bleeding Requiring Intervention post-CATH Day 1
Time frame: Assessed post-CATH Day 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terumo Control | Bleeding Requiring Intervention Post-CATH Day 1 | 0 participants |
| Terumo Fast Release | Bleeding Requiring Intervention Post-CATH Day 1 | 1 participants |
| Clo-Sur P.A.D. | Bleeding Requiring Intervention Post-CATH Day 1 | 0 participants |
p-value: 0.47Chi-squared
Secondary
Hematoma or Bruising at Discharge
Number of Participants with hematoma or bruising at discharge
Time frame: Assessed at discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terumo Control | Hematoma or Bruising at Discharge | 1 participants |
| Terumo Fast Release | Hematoma or Bruising at Discharge | 2 participants |
| Clo-Sur P.A.D. | Hematoma or Bruising at Discharge | 0 participants |
p-value: 0.372ANOVA
Secondary
Hematoma or Bruising Post-CATH Day 1
Number of Participants with hematoma or bruising post-CATH Day 1
Time frame: Assessed post-CATH day 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terumo Control | Hematoma or Bruising Post-CATH Day 1 | 4 participants |
| Terumo Fast Release | Hematoma or Bruising Post-CATH Day 1 | 4 participants |
| Clo-Sur P.A.D. | Hematoma or Bruising Post-CATH Day 1 | 7 participants |
p-value: 0.468Chi-squared
Secondary
Radial Artery Occlusion Post-CATH
Number of Participants with Radial Artery Occlusion post-CATH
Time frame: Assessed via plethysmography and palpation post-CATH
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terumo Control | Radial Artery Occlusion Post-CATH | 0 participants |
| Terumo Fast Release | Radial Artery Occlusion Post-CATH | 0 participants |
| Clo-Sur P.A.D. | Radial Artery Occlusion Post-CATH | 0 participants |
Secondary
Radial Artery Occlusion Post-CATH Day 1
Number of Participants with Radial Artery Occlusion post-CATH Day 1
Time frame: Assessed via plethysmography and palpation post-CATH day 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terumo Control | Radial Artery Occlusion Post-CATH Day 1 | 0 participants |
| Terumo Fast Release | Radial Artery Occlusion Post-CATH Day 1 | 0 participants |
| Clo-Sur P.A.D. | Radial Artery Occlusion Post-CATH Day 1 | 0 participants |
Secondary
Time to Discharge
Time to discharge in minutes.
Time frame: Assessed on day of angiogram.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Terumo Control | Time to Discharge | 178.2 minutes | Standard Deviation 50.4 |
| Terumo Fast Release | Time to Discharge | 134 minutes | Standard Deviation 45.8 |
| Clo-Sur P.A.D. | Time to Discharge | 113.7 minutes | Standard Deviation 48 |
p-value: 0.002ANOVA
p-value: <0.001ANOVA
p-value: 0.144ANOVA