Back to resultsQuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access (TRA)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quikclot Radial Pad
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Transradial Access, Hemostasis
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing CC and/or PCI via the radial artery as part of their standard of care treatment
- Patients able and willing to give written informed consent
- Patient > 18 years of age
Exclusion Criteria:
- Patients presenting with acute ST segment elevation myocardial infarction (STEMI)
Oral anticoagulation therapy as described below:
- If on a DOAC (direct acting oral anticoagulants - ie dabigatran, rivaroxaban, apixaban, endoxaban), patients will be excluded if DOAC taken within 48 hours and eGFR > 30 ml/min or DOAC taken within 72 hours and eGFR < 30 ml/min.
- If patient is on warfarin, excluded if INR > 1.5
- Liver Failure
- Life threatening illness that patient would not be expected to live more than 6 months post procedure
- Major unanticipated event in the cardiac cath lab (i.e. cardiac arrest) of an already consented patient, but before randomization, where the operator believes participation in this trial is now inappropriate.
- Thrombocytopenia, with a platelet count of < 75,000.
Sites / Locations
- Memorial Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Standard of Care (TR Band)
Quikclot Radial pad with Coban Bandage to hold the pad in place
Quikclot Radial Pad with Tegaderm dressing to hold the pad in place
Outcomes
Primary Outcome Measures
Initial successful hemostasis
Initial successful hemostasis is defined as no evidence of external bleeding from the TRA puncture site or expanding hematoma of the forearm after completion of the above described TR Band® and QuikClot® Radial® pad protocols, without the need for reinflation of air in the TR Band® or reapplication of manual pressure over the QuikClot® Radial® pad secured with either a Coban™ bandage or Tegaderm™ dressing, or use of manual compression over the arteriotomy site.
Total Time to hemostasis
Total time to hemostasis will be calculated as the time needed from sheath removal to achieving complete hemostasis, as described below:
For both the QuikClot® Radial® pad + Coban™ bandage and the QuikClot® Radial® pad + Tegaderm™ dressing arms, total time to hemostasis includes the initial 5 minutes of manual compression and 25 minutes of light compression with the Coban™ bandage in the Coban™ cohort and 5 minutes of manual compression and 25 minutes of close observation in the Tegaderm™ only cohort, and any subsequent time needed to obtain complete hemostasis. All additional protocol directed recompression and/or weaning times needed to obtain complete hemostasis will be added to calculate the total time to hemostasis.
For the standard of care TR Band® arm, total time to hemostasis includes the initial 60 minutes of compression plus 60 minutes of weaning, plus any additional protocol directed recompression and/or weaning time needed to obtain complete hemostasis.
Secondary Outcome Measures
Radial Artery Occlusion
RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test.
Full Information
NCT ID
NCT03535597
First Posted
May 2, 2018
Last Updated
January 9, 2023
Sponsor
Memorial Healthcare System
Collaborators
Z-Medica
1. Study Identification
Unique Protocol Identification Number
NCT03535597
Brief Title
QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access (TRA)
Official Title
A Randomized Comparison of the QuikClot® Radial® Pad Versus the Standard of Care TR Band® on Hemostasis After Transradial Artery Access (TRA)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
December 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Healthcare System
Collaborators
Z-Medica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of the QuikClot® Radial® pad on hemostasis after TRA, compared to the standard of care TR Band®, with the goal to hopefully develop a safe and efficacious technique to achieve more rapid patent hemostasis after TRA, and improve patient care by optimizing radial hemostasis management.
Detailed Description
The QuikClot® Radial® pad will be applied over the radial artery access site covered with either a Coban™ bandage or a Tegaderm™ dressing after TRA. Firm manual compression will then be applied over the QuikClot® Radial® pad after the sheath is removed for 5 minutes. The Coban™ cohort will then have the Coban™ bandage removed after an additional 25 minutes, then be covered with a Tegaderm™ dressing. The Tegaderm™ only cohort will be closely observed for 25 minutes after release of manual pressure. Both cohorts will remove the Tegaderm™ dressing the following morning.
Consented subjects will be randomly assigned in the cardiac cath lab upon completion of their procedure into the following three arms:
Arm 1 - Standard of Care with a TR Band® Arm 2 - QuikClot® Radial® pad combined with a Coban™ bandage Arm 3 - QuikClot® Radial® pad combined with a Tegaderm™ dressing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Transradial Access, Hemostasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomized Controlled prospective study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
No Intervention
Arm Description
Standard of Care (TR Band)
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Quikclot Radial pad with Coban Bandage to hold the pad in place
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Quikclot Radial Pad with Tegaderm dressing to hold the pad in place
Intervention Type
Device
Intervention Name(s)
Quikclot Radial Pad
Intervention Description
The QuikClot® Radial® pad will be applied over the radial artery access site covered with either a Coban™ bandage or a Tegaderm™ dressing after TRA.
Primary Outcome Measure Information:
Title
Initial successful hemostasis
Description
Initial successful hemostasis is defined as no evidence of external bleeding from the TRA puncture site or expanding hematoma of the forearm after completion of the above described TR Band® and QuikClot® Radial® pad protocols, without the need for reinflation of air in the TR Band® or reapplication of manual pressure over the QuikClot® Radial® pad secured with either a Coban™ bandage or Tegaderm™ dressing, or use of manual compression over the arteriotomy site.
Time Frame
3 hours
Title
Total Time to hemostasis
Description
Total time to hemostasis will be calculated as the time needed from sheath removal to achieving complete hemostasis, as described below:
For both the QuikClot® Radial® pad + Coban™ bandage and the QuikClot® Radial® pad + Tegaderm™ dressing arms, total time to hemostasis includes the initial 5 minutes of manual compression and 25 minutes of light compression with the Coban™ bandage in the Coban™ cohort and 5 minutes of manual compression and 25 minutes of close observation in the Tegaderm™ only cohort, and any subsequent time needed to obtain complete hemostasis. All additional protocol directed recompression and/or weaning times needed to obtain complete hemostasis will be added to calculate the total time to hemostasis.
For the standard of care TR Band® arm, total time to hemostasis includes the initial 60 minutes of compression plus 60 minutes of weaning, plus any additional protocol directed recompression and/or weaning time needed to obtain complete hemostasis.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Radial Artery Occlusion
Description
RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing CC and/or PCI via the radial artery as part of their standard of care treatment
Patients able and willing to give written informed consent
Patient > 18 years of age
Exclusion Criteria:
Patients presenting with acute ST segment elevation myocardial infarction (STEMI)
Oral anticoagulation therapy as described below:
If on a DOAC (direct acting oral anticoagulants - ie dabigatran, rivaroxaban, apixaban, endoxaban), patients will be excluded if DOAC taken within 48 hours and eGFR > 30 ml/min or DOAC taken within 72 hours and eGFR < 30 ml/min.
If patient is on warfarin, excluded if INR > 1.5
Liver Failure
Life threatening illness that patient would not be expected to live more than 6 months post procedure
Major unanticipated event in the cardiac cath lab (i.e. cardiac arrest) of an already consented patient, but before randomization, where the operator believes participation in this trial is now inappropriate.
Thrombocytopenia, with a platelet count of < 75,000.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Roberts, MD
Organizational Affiliation
Memorial Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access (TRA)
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