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

NCT02307318 | Completed Phase 1 Results

• 2 other identifiers: H&H-002Chit-002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis

Keywords

Radial Artery; Hemostasis; Angiography

Outcome Measures

Primary Outcomes (2)

• Incidence of Arterial Bleeding

  Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.

  Day1

• Incidence of Thrombosis

  Number of patients who experience thrombosis (blood clot) at the access site as measured by ultrasound between 4 hours and 24 hours post-procedure.

  4 hours post-surgery

Secondary Outcomes (2)

• Changes in Circulation, Movement and Sensation

  Day1

• Incidence of Hematoma and/or Ecchymosis

  Day1

Study Arms (1)

SoftSeal Hemostatic Pad

OTHER

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

Device: SoftSeal Hemostatic Pad

Interventions

SoftSeal Hemostatic Pad 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.

SoftSeal Hemostatic Pad

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transradial access site with a 4 French system -\>18 years old

You may not qualify if:

• Current oral anti-coagulation therapy
• Prior participation in this study
• Positive standard-of-care pregnancy test
• Patient on dialysis
• GFR \<30

Sponsors & Collaborators

• HealthEast Care System: lead
• Chitogen, Inc.: collaborator

Study Sites (1)

HealthEast Care System, Inc

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Amy Fehrer
• Organization: HealthEast Care System

afehrer@healtheast.org

651-232-5363

Study Officials

• Carmelo Panetta, MD

  HealthEast Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 11, 2017
• Results First Posted: January 11, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)