Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access (NCT03535597) | Clinical Trial Compass
CompletedNot Applicable
Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access
United States355 participantsStarted 2018-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.