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NCT02307318 · ClinicalTrials.gov registry record · Phase 1
Heart and Hands Study II: A Retrospective Data Collection & Analysis Project
A Phase 1 study, sponsored by HealthEast Care System.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT02307318 is a Phase 1 study that has completed, run by HealthEast Care System. The registered enrollment target is 51 participants.
The verdict
NCT02307318, a Phase 1 study, has completed, sponsored by HealthEast Care System.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study 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 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.
Interventions
- DEVICE SoftSeal Hemostatic Pad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-11 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02307318
The ClinicalTrials.gov registry entry for NCT02307318 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HealthEast Care System, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SoftSeal Hemostatic Pad is the first listed.
NCT02307318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02307318 about?
NCT02307318 is a clinical study titled "Heart and Hands Study II: A Retrospective Data Collection & Analysis Project". 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 lim...
What is the current status of trial NCT02307318?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2014-11. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02307318?
The interventions under investigation include: SoftSeal Hemostatic Pad (DEVICE).
Who is sponsoring clinical trial NCT02307318?
This trial is sponsored by HealthEast Care System, which has 5 total clinical trials registered on ClinicalTrials.gov.
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