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Completed

NCT Number: NCT03535597

Hemostasis With QuikClot® Radial® Pad Versus TR Band® 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing cardiac catheterization (CC) and/or percutaneous coronary intervention (PCI) via the radial artery as part of their standard of care treatment
  • Patients able and willing to give written informed consent
  • Patient > 18 years of age

Exclusion criteria

  • Patients presenting with acute ST-segment elevation myocardial infarction (STEMI)
  • Oral anticoagulation therapy as described below:
  • 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.
  • If the patient is on warfarin, excluded if INR > 1.5
  • Liver Failure
  • Life-threatening illness that the patient would not be expected to live more than 6 months post-procedure
  • 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.
  • Thrombocytopenia, with a platelet count of < 75,000.

Treatment and study plan

Quikclot Radial (QC) Pad

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.

Primary outcomes

  1. Initial Successful Hemostasis

    Time frame: 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.

  2. Total Time to Hemostasis

    Time frame: 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 outcomes

  1. Radial Artery Occlusion (RAO)

    Time frame: 1 hour

    RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test.

  2. Forearm Hematoma (EASY Classification)

    Time frame: 3 hours

    The forearm hematoma development is defined according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) classification.

  3. Incidence of Pain/Numbness of the Forearm

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Healthcare System

Other

Collaborators

  • Z-Medica

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 24, 2018
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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