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

NCT ID: NCT03535597

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 355 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-12-28

Brief Summary

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

TR Band inflated with 10 mL of air, followed by gradual weaning over the subsequent 60 minutes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2

QC pad with a Coban bandage to hold the pad in place to achieve hemostasis.

Group Type: EXPERIMENTAL

Quikclot Radial (QC) Pad

Intervention Type: DEVICE

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.

Arm 3

QC pad with a Tegaderm dressing to hold the pad in place to achieve hemostasis.

Group Type: EXPERIMENTAL

Quikclot Radial (QC) Pad

Intervention Type: DEVICE

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.

Arm 4

QC pad with a TR Band to hold the pad in place to achieve hemostasis.

Group Type: EXPERIMENTAL

Quikclot Radial (QC) Pad

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Z-Medica

INDUSTRY

Sponsor Role: collaborator

Memorial Healthcare System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Roberts, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Healthcare System

Locations

Memorial Healthcare System

Hollywood, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

QuikClot300

Identifier Type: -

Identifier Source: org_study_id