Heart and Hands Study II: A Retrospective Data Collection & Analysis Project
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2014 |
| End Date: | June 2015 |
A recent pilot study conducted at HealthEast found use of manual pressure with the SoftSeal
hemostatic pad for 15 minutes was successful in 9 out of 10 people fully anticoagluated
using 4 French radial sheath. There was no evidence of radial artery occlusion in this small
sample and bleeding was limited to grade 1. This evidence supports a larger retrospective
study to confirm these results and define an alternative to the TR band use post radial
artery access for cardiac catheterization.
Primary Objective Determine the incidence of arterial bleeding after real-world use of
SoftSeal hemostatic device at a transradial access site with a 4 French system with with
manual pressure by compression of the ulnar artery.
Secondary Objective Determine the incidence of thrombosis at the access site in all subjects
as presence of thrombus in the radial artery by reverse barbeau test; the incidence of
changes in circulation, movement and sensation (CMS) in the hand and wrist on the impacted
hand; and the incidence of hematoma and ecchymosis, assessed just prior to discharge.
hemostatic pad for 15 minutes was successful in 9 out of 10 people fully anticoagluated
using 4 French radial sheath. There was no evidence of radial artery occlusion in this small
sample and bleeding was limited to grade 1. This evidence supports a larger retrospective
study to confirm these results and define an alternative to the TR band use post radial
artery access for cardiac catheterization.
Primary Objective Determine the incidence of arterial bleeding after real-world use of
SoftSeal hemostatic device at a transradial access site with a 4 French system with with
manual pressure by compression of the ulnar artery.
Secondary Objective Determine the incidence of thrombosis at the access site in all subjects
as presence of thrombus in the radial artery by reverse barbeau test; the incidence of
changes in circulation, movement and sensation (CMS) in the hand and wrist on the impacted
hand; and the incidence of hematoma and ecchymosis, assessed just prior to discharge.
This is a non-randomized, retrospective study to observe the usefulness of SoftSeal. Only
patients with radial procedures will be used in this study.
Study Procedure For patients with a 4 French catheter, SoftSeal will be applied per
physician instruction. Current protocol for use includes compression of ulnar artery on the
same visit.
Any bleeding observed at the site after manual pressure hold with SoftSeal will constitute a
failure to achieve hemostasis patient will be managed per standard of care (SOC).
Data Plan Following completion of clinical care we will extract data related to primary and
secondary objectives. Data extraction will include documentation of CMS, reverse Barbeau and
incidence of hematoma and ecchymosis. Any additional statistical analysis or manuscript
writing will be done as part of a separate agreement to be met with the approval of both
HaelaTheast Medical Research Institute and Chitogen.
Sample Size Calculation Since this is a real-world data analysis project with no control
group, there is not a sample size calculation. We believe 50 patients will be enough to
provide an understanding of use instructions for the SoftSeal product.
patients with radial procedures will be used in this study.
Study Procedure For patients with a 4 French catheter, SoftSeal will be applied per
physician instruction. Current protocol for use includes compression of ulnar artery on the
same visit.
Any bleeding observed at the site after manual pressure hold with SoftSeal will constitute a
failure to achieve hemostasis patient will be managed per standard of care (SOC).
Data Plan Following completion of clinical care we will extract data related to primary and
secondary objectives. Data extraction will include documentation of CMS, reverse Barbeau and
incidence of hematoma and ecchymosis. Any additional statistical analysis or manuscript
writing will be done as part of a separate agreement to be met with the approval of both
HaelaTheast Medical Research Institute and Chitogen.
Sample Size Calculation Since this is a real-world data analysis project with no control
group, there is not a sample size calculation. We believe 50 patients will be enough to
provide an understanding of use instructions for the SoftSeal product.
Inclusion Criteria:
- Transradial access site with a 4 French system ->18 years old
Exclusion Criteria:
- Current oral anti-coagulation therapy
- Prior participation in this study
- Positive standard-of-care pregnancy test
- Investigator discretionary exclusions
- Patient on dialysis
- GFR <30
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