Clinical trial NCT02307318: Heart and Hands Study II: A Retrospective Data Collection & Analysis Project
Official title: Heart and Hands Study II: A Retrospective Data Collection & Analysis Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Thrombosis
Keywords: Radial Artery
Hemostasis
Angiography
Lead sponsor: HealthEast Care System
Sponsor class: OTHER
Collaborators: name: Chitogen, Inc.
First posted: 2014-12-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Incidence of Arterial Bleeding
timeFrame: Day1
measure: Incidence of Thrombosis
timeFrame: 4 hours post-surgery
Secondary outcomes:
measure: Changes in Circulation, Movement and Sensation
timeFrame: Day1
measure: Incidence of Hematoma and/or Ecchymosis
timeFrame: Day1
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: HealthEast Care System, Inc
state: Minnesota
Study officials:
affiliation: HealthEast Care System
name: Carmelo Panetta, MD
role: PRINCIPAL_INVESTIGATOR
References: