Heart and Hands Study II: A Retrospective Data Collection & Analysis Project

Thrombosis Clinical Trial

Official title:

Heart and Hands Study II: A Retrospective Data Collection & Analysis Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307318
• Other study ID #: H&H-002
• Secondary ID: Chit-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 26, 2014
• Last updated: September 28, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: HealthEast Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Thrombosis

Intervention

Device:
• SoftSeal - STF Hemostatic Pad
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.

Locations

Country	Name	City	State
United States	HealthEast Care System, Inc	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthEast Care System	Chitogen, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial bleeding		Day1	No
Primary	incidence of thrombosis		4 hours post-surgery	No
Secondary	circulation		Day1	No
Secondary	incidence of hematoma		Day1	No
Secondary	movement		Day1	No
Secondary	sensation		Day1	No
Secondary	incidence of ecchymosis		Day1	No