Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access

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

To evaluate the efficacy and safety of the QuikClot® Radial® pad on hemostasis after transradial access (TRA), compared to the standard of care TR Band®, 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 (QC) Pad

Detailed Description

The QuikClot® Radial® (QC) 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 QC 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 one of the following arms:

Arm 1 - Standard of Care with a TR Band®

Arm 2 - QC pad combined with a Coban™ bandage

Arm 3 - QC pad combined with a Tegaderm™ dressing. This arm was stopped after the enrollment of 73 patients and replaced by the QC/TR Band® arm

Arm 4- QC pad was applied on the radial arterial access site with 30 minutes of compression under a TR Band® inflated with 8-10 mL of air. Then the TR Band® was removed, leaving the QC pad covered with a Tegaderm™ dressing.

• Study Type: Interventional
• Enrollment (Actual): 355
• 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

Description

Inclusion Criteria:

1. Patients undergoing cardiac catheterization (CC) and/or percutaneous coronary intervention (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, edoxaban), 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 the patient is on warfarin, excluded if INR > 1.5
3. Liver Failure
4. Life-threatening illness that the 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1; TR Band inflated with 10 mL of air, followed by gradual weaning over the subsequent 60 minutes.
Experimental: Arm 2; QC pad with a Coban bandage to hold the pad in place to achieve hemostasis.	Device: Quikclot Radial (QC) Pad; The QC pad will be applied over the radial artery access site covered with either a Coban™ bandage, a Tegaderm™ dressing, or a TR Band after TRA.
Experimental: Arm 3; QC pad with a Tegaderm dressing to hold the pad in place to achieve hemostasis.	Device: Quikclot Radial (QC) Pad; The QC pad will be applied over the radial artery access site covered with either a Coban™ bandage, a Tegaderm™ dressing, or a TR Band after TRA.
Experimental: Arm 4; QC pad with a TR Band to hold the pad in place to achieve hemostasis.	Device: Quikclot Radial (QC) Pad; The QC pad will be applied over the radial artery access site covered with either a Coban™ bandage, a Tegaderm™ dressing, or a TR Band 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 was calculated as the time needed from sheath removal to achieving complete hemostasis. All additional protocol-directed recompression and/or weaning times needed to obtain complete hemostasis were added to calculate the total time to hemostasis.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery Occlusion (RAO)	RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test.	1 hour
Forearm Hematoma (EASY Classification)	The forearm hematoma development is defined according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) classification.	3 hours
Incidence of Pain/Numbness of the Forearm	Self-reported pain/numbness was evaluated using a verbal numeric rating scale (VNRS), ranging from 0 for no pain to 10 for the worst pain, one hour after hemostasis was obtained.	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 (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: July 1, 2024

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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes