QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access (TRA)

A Randomized Comparison of the QuikClot® Radial® Pad Versus the Standard of Care TR Band® on Hemostasis After Transradial Artery Access (TRA)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Quikclot Radial Pad

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

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients undergoing CC and/or PCI via the radial artery as part of their standard of care treatment
2. Patients able and willing to give written informed consent
3. Patient > 18 years of age

Exclusion Criteria:

1. Patients presenting with acute ST segment elevation myocardial infarction (STEMI)

2. Oral anticoagulation therapy as described below:

   1. 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.
   2. If patient is on warfarin, excluded if INR > 1.5
3. Liver Failure
4. Life threatening illness that patient would not be expected to live more than 6 months post procedure
5. 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.
6. Thrombocytopenia, with a platelet count of < 75,000.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1; Standard of Care (TR Band)
Experimental: Arm 2; Quikclot Radial pad with Coban Bandage to hold the pad in place	Device: Quikclot Radial Pad; 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.
Experimental: Arm 3; Quikclot Radial Pad with Tegaderm dressing to hold the pad in place	Device: Quikclot Radial Pad; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 hours
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.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery Occlusion	RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test.	1 hour

Collaborators and Investigators

• Sponsor: Memorial Healthcare System
• Collaborators: Z-Medica
• Investigators: Principal Investigator: Jonathan Roberts, MD, Memorial Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): December 28, 2022
• Study Completion (Actual): December 28, 2022

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Hemostasis; Transradial Access
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: QuikClot300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No