Status:
COMPLETED
Heart and Hands Study II: A Retrospective Data Collection & Analysis Project
Lead Sponsor:
HealthEast Care System
Collaborating Sponsors:
Chitogen, Inc.
Conditions:
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 radia...
Detailed Description
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 cath...
Eligibility Criteria
Inclusion
- Transradial access site with a 4 French system -\>18 years old
Exclusion
- Current oral anti-coagulation therapy
- Prior participation in this study
- Positive standard-of-care pregnancy test
- Investigator discretionary exclusions
- Patient on dialysis
- GFR \<30
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02307318
Start Date
November 1 2014
End Date
June 1 2015
Last Update
January 11 2017
Active Locations (1)
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1
HealthEast Care System, Inc
Saint Paul, Minnesota, United States, 55102