QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access (TRA)
Status: | Recruiting |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/24/2018 |
Start Date: | August 1, 2018 |
End Date: | December 1, 2019 |
Contact: | Jianli Niu, MD, PhD |
Email: | jniu@mhs.net |
Phone: | 954-265-6653 |
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.
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.
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
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
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.
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