Trial Outcomes & Findings for Caring for the Radial Artery Post-angiogram (NCT NCT01326455)
NCT ID: NCT01326455
Last Updated: 2022-09-28
Results Overview
Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Assessed after initial hemostasis achieved
Results posted on
2022-09-28
Participant Flow
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.
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.
Participant milestones
| Measure |
Terumo Control
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation.
|
Terumo Fast Release
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation.
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
15
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caring for the Radial Artery Post-angiogram
Baseline characteristics by cohort
| Measure |
Terumo Control
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation
|
Terumo Fast Release
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation.
|
Clo-Sur P.A.D.
n=25 Participants
A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
62.1 years
STANDARD_DEVIATION 8.3 • n=107 Participants
|
64.1 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
63.2 years
STANDARD_DEVIATION 10 • n=7 Participants
|
|
Age, Customized
>=18 years
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
25 participants
n=206 Participants
|
75 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
64 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
25 participants
n=206 Participants
|
75 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Assessed after initial hemostasis achievedNumber of Participants with Bleeding Requiring Intervention after initial hemostasis achieved
Outcome measures
| Measure |
Terumo Control
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation.
|
Terumo Fast Release
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation.
|
Clo-Sur P.A.D.
n=25 Participants
A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1
|
|---|---|---|---|
|
Bleeding Requiring Intervention After Initial Hemostasis Achieved
|
2 participants
|
6 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Assessed post-CATH Day 1Population: 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.
Number of Participants with Bleeding Requiring Intervention post-CATH Day 1
Outcome measures
| Measure |
Terumo Control
n=15 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation.
|
Terumo Fast Release
n=20 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation.
|
Clo-Sur P.A.D.
n=18 Participants
A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1
|
|---|---|---|---|
|
Bleeding Requiring Intervention Post-CATH Day 1
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Assessed on day of angiogram.Time to discharge in minutes.
Outcome measures
| Measure |
Terumo Control
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation.
|
Terumo Fast Release
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation.
|
Clo-Sur P.A.D.
n=25 Participants
A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1
|
|---|---|---|---|
|
Time to Discharge
|
178.2 minutes
Standard Deviation 50.4
|
134 minutes
Standard Deviation 45.8
|
113.7 minutes
Standard Deviation 48.0
|
SECONDARY outcome
Timeframe: Assessed at dischargeNumber of Participants with hematoma or bruising at discharge
Outcome measures
| Measure |
Terumo Control
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation.
|
Terumo Fast Release
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation.
|
Clo-Sur P.A.D.
n=25 Participants
A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1
|
|---|---|---|---|
|
Hematoma or Bruising at Discharge
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Assessed post-CATH day 1.Number of Participants with hematoma or bruising post-CATH Day 1
Outcome measures
| Measure |
Terumo Control
n=14 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation.
|
Terumo Fast Release
n=18 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation.
|
Clo-Sur P.A.D.
n=17 Participants
A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1
|
|---|---|---|---|
|
Hematoma or Bruising Post-CATH Day 1
|
4 participants
|
4 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Assessed via plethysmography and palpation post-CATHNumber of Participants with Radial Artery Occlusion post-CATH
Outcome measures
| Measure |
Terumo Control
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation.
|
Terumo Fast Release
n=25 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation.
|
Clo-Sur P.A.D.
n=25 Participants
A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1
|
|---|---|---|---|
|
Radial Artery Occlusion Post-CATH
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Assessed via plethysmography and palpation post-CATH day 1.Number of Participants with Radial Artery Occlusion post-CATH Day 1
Outcome measures
| Measure |
Terumo Control
n=15 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 1 hour after final deflation.
|
Terumo Fast Release
n=20 Participants
A transparent unilateral compression device secured to the wrist via strap with velcro that was removed 15 minutes after final deflation.
|
Clo-Sur P.A.D.
n=18 Participants
A hydrophilic dressing with a high affinity for water and absorbs and controls body fluid that was removed on post-CATH day 1
|
|---|---|---|---|
|
Radial Artery Occlusion Post-CATH Day 1
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Terumo Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Terumo Fast Release
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clo-Sur P.A.D.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place