Thrombosis
Conditions
Keywords
Radial Artery, Hemostasis, Angiography
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.
Interventions
DEVICESoftSeal 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
Chitogen, Inc.
HealthEast Care System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Arterial Bleeding | 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. |
| Incidence of Thrombosis | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Circulation, Movement and Sensation | 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. |
| Incidence of Hematoma and/or Ecchymosis | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SoftSeal Hemostatic Pad This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | SoftSeal Hemostatic Pad |
|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 8.7 |
| Gender Female | 22 Participants |
| Gender Male | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 51 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
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.
Time frame: Day1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal Hemostatic Pad | Incidence of Arterial Bleeding | 1 Participants |
Primary
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.
Time frame: 4 hours post-surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal Hemostatic Pad | Incidence of Thrombosis | 0 Participants |
Secondary
Changes in Circulation, Movement and Sensation
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.
Time frame: Day1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal Hemostatic Pad | Changes in Circulation, Movement and Sensation | 0 Participants |
Secondary
Incidence of Hematoma and/or Ecchymosis
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.
Time frame: Day1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SoftSeal Hemostatic Pad | Incidence of Hematoma and/or Ecchymosis | 0 Participants |