Coronary Artery DiseaseNCT03535597

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

A study testing Quikclot Radial (QC) Pad in people with Coronary Artery Disease, run by Memorial Healthcare System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Quikclot Radial (QC) Pad
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 355 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2018to 28 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Memorial Healthcare System
Hollywood, Florida, 33021

Other trials in United States

About this study

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

Read the 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
Being tested: Quikclot Radial (QC) Pad
Keywords: Transradial Access, Hemostasis
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quikclot Radial (QC) PadDevice
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.

Study groups in NCT03535597
Study group	Role	What they receive
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. Receives: Device: Quikclot Radial (QC) Pad
Arm 3	Experimental	QC pad with a Tegaderm dressing to hold the pad in place to achieve hemostasis. Receives: Device: Quikclot Radial (QC) Pad
Arm 4	Experimental	QC pad with a TR Band to hold the pad in place to achieve hemostasis. Receives: Device: Quikclot Radial (QC) Pad

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 3 hours

Secondary outcomes (3)

Radial Artery Occlusion (RAO)
RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test.
Measured: 1 hour
Forearm Hematoma (EASY Classification)
The forearm hematoma development is defined according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) classification.
Measured: 3 hours
Incidence of Pain/Numbness of the Forearm
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.
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201828 Dec 2022

First posted24 May 2018
Study start1 Aug 2018
Primary completion28 Dec 2022
Study completion28 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Randomized Controlled prospective study
Masking: None (open label)
Enrolment: 355 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03535597
Sponsor's protocol ID: QuikClot300
Status last verified: Jul 2024
First submitted: 2 May 2018
Last updated: 24 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Comparison of the QuikClot® Radial® Pad Versus the Standard of Care TR Band® on Hemostasis After Transradial Artery Access
ClinicalTrials.gov ID: NCT03535597
Acronym / sponsor ID: QuikClot300
Conditions: Coronary Artery Disease
Keywords: Transradial Access, Hemostasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 355 participants (actual)
Lead sponsor: Memorial Healthcare SystemUniversity, hospital or other
Collaborators: Z-Medica
Study start: 1 Aug 2018 (actual)
Primary completion: 28 Dec 2022 (actual)
Study completion: 28 Dec 2022 (actual)
First posted: 24 May 2018 (actual)
Results: Posted 24 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4
Model description: Randomized Controlled prospective study

Arm	Type	Receives
Arm 1	No intervention	–TR Band inflated with 10 mL of air, followed by gradual weaning over the subsequent 60 minutes.
Arm 2	Experimental	Device: Quikclot Radial (QC) PadQC pad with a Coban bandage to hold the pad in place to achieve hemostasis.
Arm 3	Experimental	Device: Quikclot Radial (QC) PadQC pad with a Tegaderm dressing to hold the pad in place to achieve hemostasis.
Arm 4	Experimental	Device: Quikclot Radial (QC) PadQC pad with a TR Band to hold the pad in place to achieve hemostasis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

Patients presenting with acute ST-segment elevation myocardial infarction (STEMI)
Oral anticoagulation therapy as described below:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quikclot Radial (QC) PadThe 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.	Device	Arm 2, Arm 3, Arm 4

Primary outcome

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.
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.

3 secondary outcomes

Radial Artery Occlusion (RAO)
Time frame: 1 hour
Forearm Hematoma (EASY Classification)
Time frame: 3 hours
Incidence of Pain/Numbness of the Forearm
Time frame: 1 hour

Results and safety

Results posted to the registry on 24 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1	96	96
Arm 2	100	100
Arm 3	73	73
Arm 4	86	86

Primary outcome: Initial Successful Hemostasis

Time frame: 3 hours. Count of participants. Unit: Participants

Measure	Arm 1 n = 96	Arm 2 n = 100	Arm 3 n = 73	Arm 4 n = 86
Value	85	88	51	74

Arm 1 vs Arm 2: Risk Ratio (RR): 0.99 (95% CI 0.89 to 1.11), p = 0.906, Chi-squared
Arm 1 vs Arm 3: Risk Ratio (RR): 1.27 (95% CI 1.09 to 1.53), p = 0.002, Chi-squared
Arm 1 vs Arm 4: Risk Ratio (RR): 0.97 (95% CI 0.86 to 1.09), p = 0.613, Chi-squared

Primary outcome: Total Time to Hemostasis

Time frame: 3 hours. Mean (Standard Deviation). Unit: minutes

Measure	Arm 1 n = 96	Arm 2 n = 100	Arm 3 n = 73	Arm 4 n = 86
Value	131.5 (29.8)	33.3 (9.6)	10.9 (20.4)	37.2 (17.3)

Arm 1 vs Arm 2: Mean Difference (Net): -98.5, p <0.001, t-test, 2 sided
Arm 1 vs Arm 3: Mean Difference (Net): -120.6, p < 0.001, t-test, 2 sided
Arm 1 vs Arm 4: Mean Difference (Net): -94.3, p < 0.001, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	0 of 96 (0%)	0 of 96 (0%)	0 of 96
Arm 2	0 of 100 (0%)	0 of 100 (0%)	0 of 100
Arm 3	0 of 73 (0%)	0 of 73 (0%)	0 of 73
Arm 4	0 of 86 (0%)	0 of 86 (0%)	0 of 86

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonathan Roberts, MD principal investigator

Memorial Healthcare System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Quikclot Radial (QC) Pad in people with Coronary Artery Disease, run by Memorial Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initial Successful Hemostasis (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03535597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.