Clinical trial NCT03535597: Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access
Official title: A Randomized Comparison of the QuikClot® Radial® Pad Versus the Standard of Care TR Band® on Hemostasis After Transradial Artery Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Transradial Access
Hemostasis
Lead sponsor: Memorial Healthcare System
Sponsor class: OTHER
Collaborators: name: Z-Medica
First posted: 2018-05-24
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized Controlled prospective study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Initial Successful Hemostasis
timeFrame: 3 hours
measure: Total Time to Hemostasis
timeFrame: 3 hours
Secondary outcomes:
measure: Radial Artery Occlusion (RAO)
timeFrame: 1 hour
measure: Forearm Hematoma (EASY Classification)
timeFrame: 3 hours
measure: Incidence of Pain/Numbness of the Forearm
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
Study officials:
affiliation: Memorial Healthcare System
name: Jonathan Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References: