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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Quikclot Radial (QC) Pad

• Registration Number: NCT03535597
• Lead Sponsor: Memorial Healthcare System

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

Study Timeline

• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-05-24
• Study Start: 2018-08-01
• Primary Completion: 2022-12-28
• Study Completion: 2022-12-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 2	Quikclot Radial (QC) Pad	QC pad with a Coban bandage to hold the pad in place to achieve hemostasis.
Arm 3	Quikclot Radial (QC) Pad	QC pad with a Tegaderm dressing to hold the pad in place to achieve hemostasis.
Arm 4	Quikclot Radial (QC) Pad	QC pad with a TR Band to hold the pad in place to achieve hemostasis.

Primary Outcome Measures

Name	Time	Method
Initial Successful Hemostasis	3 hours	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	3 hours	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.

Secondary Outcome Measures

Name	Time	Method
Radial Artery Occlusion (RAO)	1 hour	RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test.
Forearm Hematoma (EASY Classification)	3 hours	The forearm hematoma development is defined according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) classification.
Incidence of Pain/Numbness of the Forearm	1 hour	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.

Trial Locations

Locations (1)

Memorial Healthcare System; 🇺🇸 Hollywood, Florida, United States