Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Z-Medica | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Arm 3 | Experimental | QC pad with a Tegaderm dressing to hold the pad in place to achieve hemostasis. |
|
| Arm 4 | Experimental | QC pad with a TR Band to hold the pad in place to achieve hemostasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radial Artery Occlusion (RAO) | RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Thrombocytopenia, with a platelet count of < 75,000.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Roberts, MD | Memorial Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients less than 18 years old, acute ST segment elevation myocardial infarction, pregnancy, inability to consent, inability or refusal to allow a follow-up visit or telephone call one business day after the procedure, and arterial access using an ulnar or femoral approach were excluded.
Participants ≥ 18 years of age willing to give written informed consent were randomized immediately after the completion of the procedure at the cath lab using the randomization sequence.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Patients randomly assigned to this arm received 60 min of mechanical compression with a TR Band inflated with 10 mL of air, followed by gradual weaning over the subsequent 60 min. 96 patients who had undergone successful radial access were enrolled in this arm. |
| FG001 | Arm 2 | Patients randomly assigned to this arm received the QC pad with 5 minutes of manual pressure followed by 25 minutes of light compression with a Coban™ bandage. 100 patients who had undergone successful radial access were enrolled in this arm. |
| FG002 | Arm 3 | Patients randomly assigned to this arm received the QC pad with 5 min of manual pressure followed by a Tegaderm™ dressing. 73 subjects who had undergone successful radial access were enrolled in this arm. |
| FG003 | Arm 4 | Patients were assigned to this arm received the QC pad under a TR Band with 30 minutes of compression by the inflated TR Band®. 86 patients who had undergone successful radial access were enrolled in this arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TR Band | Patients randomly assigned to this arm received 60 min of mechanical compression with a TR Band inflated with 10 mL of air, followed by gradual weaning over the subsequent 60 min. 96 patients who had undergone successful radial access were enrolled in this arm. |
| BG001 | QC/Coban Bandage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 3 hours |
|
24 hours
pseudoaneurysm or any other vascular complications during the observation period. Access site bleeding requires surgery or special medical intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Standard of care TR Band | 0 |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jianli Niu | Memorial Healthcare Systerm | 954-265-6653 | jniu@mhs.net |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2019 | Jan 29, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Randomized Controlled prospective study
Not provided
Not provided
Not provided
Not provided
| 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. | 1 hour |
Patients randomly assigned to this arm received the QC pad with 5 minutes of manual pressure followed by 25 minutes of light compression with a Coban™ bandage. 100 patients who had undergone successful radial access were enrolled in this arm. |
| BG002 | QC/Trgaderm Dressing | Patients randomly assigned to this arm received the QC pad with 5 min of manual pressure followed by a Tegaderm™ dressing. 73 subjects who had undergone successful radial access were enrolled in this arm. |
| BG003 | QC/TR Band | Patients were assigned to this arm received the QC pad under a TR Band with 30 minutes of compression by the inflated TR Band®. 86 patients who had undergone successful radial access were enrolled in this arm. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Dyslipidemia | Count of Participants | Participants |
|
| Family history of CAD | Count of Participants | Participants |
|
| Aspirin use | Count of Participants | Participants |
|
| Oral anticoagulant | Count of Participants | Participants |
|
| OG002 | Arm 3 | QC/Tegaderm dressing |
| OG003 | Arm 4 | QC/TR Band |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes | 3 hours |
|
|
|
|
| Secondary | Radial Artery Occlusion (RAO) | RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test. | Posted | Count of Participants | Participants | 1 hour |
|
|
|
|
| Secondary | Forearm Hematoma (EASY Classification) | The forearm hematoma development is defined according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) classification. | Posted | Count of Participants | Participants | 3 hours |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 hour |
|
|
|
|
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Arm 2 | QC/Coban bandage | 0 | 100 | 0 | 100 | 0 | 100 |
| EG002 | Arm 3 | QC/Tegaderm dressing | 0 | 73 | 0 | 73 | 0 | 73 |
| EG003 | Arm 4 | QC/TR Band | 0 | 86 | 0 | 86 | 0 | 86 |
Not provided
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Mean Difference (Net) |
| -120.6 |
| 2-Sided |
| Other |
| t-test, 2 sided | < 0.001 | Mean Difference (Net) | -94.3 | 2-Sided | Other |
| Risk Ratio (RR) |
| 1.02 |
| 2-Sided |
| 95 |
| 0.31 |
| 3.41 |
| Other |
| Fisher Exact | 0.724 | Risk Ratio (RR) | 0.67 | 2-Sided | 95 | 0.18 | 2.46 | Other |
| Risk Ratio (RR) |
| 1.10 |
| 2-Sided |
| 95 |
| 0.37 |
| 3.26 |
| Other |
| Fisher Exact | 0.581 | Risk Ratio (RR) | 1.45 | 2-Sided | 95 | 0.55 | 3.88 | Other |
| Risk Ratio (RR) |
| 2.10 |
| 2-Sided |
| 95 |
| 0.75 |
| 5.9 |
| Other |
| Fisher Exact | 0.266 | Risk Ratio (RR) | 2.01 | 2-Sided | 95 | 0.74 | 5.54 | Other |