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

NCT ID: NCT02307318

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-06-30

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 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.

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 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 approximately 50 patients will be enough to provide an understanding of use instructions for the SoftSeal product.

Conditions

Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SoftSeal Hemostatic Pad

This is a single arm study. All patients received the SoftSeal hemostatic pad for compression following elective or urgent coronary angiogram.

Group Type: OTHER

SoftSeal Hemostatic Pad

Intervention Type: DEVICE

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.

Interventions

SoftSeal 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chitogen, Inc.

INDIV

Sponsor Role: collaborator

HealthEast Care System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmelo Panetta, MD

Role: PRINCIPAL_INVESTIGATOR

HealthEast Care System

Locations

HealthEast Care System, Inc

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

Chit-002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H&H-002

Identifier Type: -

Identifier Source: org_study_id