Coronary Artery Disease
Conditions
Keywords
Transradial Access, Hemostasis
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.
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.
Interventions
DEVICEQuikclot Radial (QC) Pad
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.
Sponsors
Z-Medica
Memorial Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing cardiac catheterization (CC) and/or percutaneous coronary intervention (PCI) via the radial artery as part of their standard of care treatment 2. Patients able and willing to give written informed consent 3. Patient \> 18 years of age
Exclusion criteria
1. Patients presenting with acute ST-segment elevation myocardial infarction (STEMI) 2. Oral anticoagulation therapy as described below: 1. 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. 2. If the patient is on warfarin, excluded if INR \> 1.5 3. Liver Failure 4. Life-threatening illness that the patient would not be expected to live more than 6 months post-procedure 5. 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. 6. Thrombocytopenia, with a platelet count of \< 75,000.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial Successful Hemostasis | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Radial Artery Occlusion (RAO) | 1 hour | RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test. |
| Forearm Hematoma (EASY Classification) | 3 hours | The forearm hematoma development is defined according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) classification. |
| Incidence of Pain/Numbness of the Forearm | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 96 |
| QC/Coban Bandage 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. | 100 |
| 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. | 73 |
| 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. | 86 |
| Total | 355 |
Baseline characteristics
| Characteristic | TR Band | QC/Coban Bandage | QC/Trgaderm Dressing | QC/TR Band | Total |
|---|---|---|---|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 15.3 | 65.2 years STANDARD_DEVIATION 11.4 | 67.1 years STANDARD_DEVIATION 13.3 | 64.3 years STANDARD_DEVIATION 13.8 | 65.8 years STANDARD_DEVIATION 13.5 |
| Aspirin use | 88 Participants | 90 Participants | 71 Participants | 70 Participants | 319 Participants |
| BMI | 29.9 kg/m^2 STANDARD_DEVIATION 6.5 | 30.3 kg/m^2 STANDARD_DEVIATION 7.3 | 29.4 kg/m^2 STANDARD_DEVIATION 6.2 | 30.1 kg/m^2 STANDARD_DEVIATION 8.5 | 29.9 kg/m^2 STANDARD_DEVIATION 7.1 |
| Diabetes mellitus | 42 Participants | 40 Participants | 30 Participants | 32 Participants | 144 Participants |
| Dyslipidemia | 62 Participants | 71 Participants | 52 Participants | 59 Participants | 244 Participants |
| Family history of CAD | 1 Participants | 3 Participants | 3 Participants | 6 Participants | 13 Participants |
| Hypertension | 80 Participants | 81 Participants | 62 Participants | 69 Participants | 292 Participants |
| Oral anticoagulant | 9 Participants | 12 Participants | 11 Participants | 7 Participants | 39 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Black | 18 Participants | 17 Participants | 10 Participants | 13 Participants | 58 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 75 Participants | 79 Participants | 62 Participants | 67 Participants | 283 Participants |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 19 Participants | 19 Participants | 89 Participants |
| Sex: Female, Male Male | 70 Participants | 75 Participants | 54 Participants | 67 Participants | 266 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 100 | 0 / 73 | 0 / 86 |
| other Total, other adverse events | 0 / 96 | 0 / 100 | 0 / 73 | 0 / 86 |
| serious Total, serious adverse events | 0 / 96 | 0 / 100 | 0 / 73 | 0 / 86 |
Outcome results
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.
Time frame: 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Initial Successful Hemostasis | 85 Participants |
| Arm 2 | Initial Successful Hemostasis | 88 Participants |
| Arm 3 | Initial Successful Hemostasis | 51 Participants |
| Arm 4 | Initial Successful Hemostasis | 74 Participants |
p-value: 0.90695% CI: [0.89, 1.11]Chi-squared
p-value: 0.00295% CI: [1.09, 1.53]Chi-squared
p-value: 0.61395% CI: [0.86, 1.09]Chi-squared
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.
Time frame: 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Total Time to Hemostasis | 131.5 minutes | Standard Deviation 29.8 |
| Arm 2 | Total Time to Hemostasis | 33.3 minutes | Standard Deviation 9.6 |
| Arm 3 | Total Time to Hemostasis | 10.9 minutes | Standard Deviation 20.4 |
| Arm 4 | Total Time to Hemostasis | 37.2 minutes | Standard Deviation 17.3 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Forearm Hematoma (EASY Classification)
The forearm hematoma development is defined according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) classification.
Time frame: 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Forearm Hematoma (EASY Classification) | 6 Participants |
| Arm 2 | Forearm Hematoma (EASY Classification) | 9 Participants |
| Arm 3 | Forearm Hematoma (EASY Classification) | 5 Participants |
| Arm 4 | Forearm Hematoma (EASY Classification) | 8 Participants |
p-value: 0.59495% CI: [0.56, 3.76]Fisher Exact
p-value: >0.99995% CI: [0.37, 3.26]Fisher Exact
p-value: 0.58195% CI: [0.55, 3.88]Fisher Exact
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.
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Incidence of Pain/Numbness of the Forearm | 5 Participants |
| Arm 2 | Incidence of Pain/Numbness of the Forearm | 10 Participants |
| Arm 3 | Incidence of Pain/Numbness of the Forearm | 8 Participants |
| Arm 4 | Incidence of Pain/Numbness of the Forearm | 9 Participants |
p-value: 0.28495% CI: [0.71, 5.22]Fisher Exact
p-value: 0.24395% CI: [0.75, 5.9]Fisher Exact
p-value: 0.26695% CI: [0.74, 5.54]Fisher Exact
Secondary
Radial Artery Occlusion (RAO)
RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test.
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Radial Artery Occlusion (RAO) | 5 Participants |
| Arm 2 | Radial Artery Occlusion (RAO) | 4 Participants |
| Arm 3 | Radial Artery Occlusion (RAO) | 4 Participants |
| Arm 4 | Radial Artery Occlusion (RAO) | 3 Participants |
p-value: 0.74495% CI: [0.23, 2.57]Fisher Exact
p-value: >0.99995% CI: [0.31, 3.41]Fisher Exact
p-value: 0.72495% CI: [0.18, 2.46]Fisher Exact