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

NCT03535597 | Completed Results FDA Device

• 1 other identifier: QuikClot300
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Transradial Access; Hemostasis

Outcome Measures

Primary Outcomes (2)

• Initial Successful Hemostasis

  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.

  3 hours

• Total Time to Hemostasis

  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.

  3 hours

Secondary Outcomes (3)

• Radial Artery Occlusion (RAO)

  1 hour

• Forearm Hematoma (EASY Classification)

  3 hours

• Incidence of Pain/Numbness of the Forearm

  1 hour

Study Arms (4)

Arm 1

NO INTERVENTION

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

Arm 2

EXPERIMENTAL

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

Device: Quikclot Radial (QC) Pad

Arm 3

EXPERIMENTAL

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

Device: Quikclot Radial (QC) Pad

Arm 4

EXPERIMENTAL

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

Device: Quikclot Radial (QC) Pad

Interventions

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.

Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Healthcare System: lead
• Z-Medica: collaborator

Study Sites (1)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This is a single-center study that used the QuikClot® Radial® Pad for hemostasis after radial artery access. There is limited past data on the efficacy of this product that has not been widely used in the past for radial artery hemostasis. The points of view expressed in this report are solely those of the investigative team and do not necessarily represent those of their affiliated organizations or the sponsor, and do not provide a concrete basis for the development of practice guidelines.

Results Point of Contact

• Title: Dr. Jianli Niu
• Organization: Memorial Healthcare Systerm

jniu@mhs.net

954-265-6653

Study Officials

• Jonathan Roberts, MD

  Memorial Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled prospective study

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 24, 2018
• Study Start: August 1, 2018
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)