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

NCT02307318 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-01-11

Study results available
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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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Chitogen, Inc.

    collaborator INDIV

  • HealthEast Care System

    lead OTHER

Principal Investigators

  • Carmelo Panetta, MD · HealthEast Care System

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02307318 on ClinicalTrials.gov