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Completed

NCT Number: NCT02307318

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 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.

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

HealthEast Care System, Inc

Saint Paul, Minnesota, 55102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Arterial Bleeding

    Time frame: Day1

    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.

  2. Incidence of Thrombosis

    Time frame: 4 hours post-surgery

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

Secondary outcomes

  1. Changes in Circulation, Movement and Sensation

    Time frame: Day1

    Number of patients who experience changes in circulation, movement and sensation in the hand and wrist of the access site as measured by standard of care nursing assessments.

  2. Incidence of Hematoma and/or Ecchymosis

    Time frame: Day1

    Number of patients who experience hematoma (bruising) and/or ecchymosis (discoloration of the skin caused by bleeding underneath) at the access site as measured by observation just prior to discharge.

Sponsors and collaborators

Lead sponsor

HealthEast Care System

Other

Collaborators

  • Chitogen, Inc.

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2014
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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