Trial Outcomes & Findings for Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access (NCT NCT03535597)

Last Updated: 2024-09-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

355 participants

Primary outcome timeframe

3 hours

Results posted on

2024-09-24

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	96	100	73	86
Overall Study COMPLETED	96	100	73	86
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TR Band n=96 Participants 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.	QC/Coban Bandage n=100 Participants 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.	QC/Trgaderm Dressing n=73 Participants 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.	QC/TR Band n=86 Participants 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.	Total n=355 Participants Total of all reporting groups
Age, Continuous	66.6 years STANDARD_DEVIATION 15.3 • n=5 Participants	65.2 years STANDARD_DEVIATION 11.4 • n=7 Participants	67.1 years STANDARD_DEVIATION 13.3 • n=5 Participants	64.3 years STANDARD_DEVIATION 13.8 • n=4 Participants	65.8 years STANDARD_DEVIATION 13.5 • n=21 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	25 Participants n=7 Participants	19 Participants n=5 Participants	19 Participants n=4 Participants	89 Participants n=21 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	75 Participants n=7 Participants	54 Participants n=5 Participants	67 Participants n=4 Participants	266 Participants n=21 Participants
Race/Ethnicity, Customized Black	18 Participants n=5 Participants	17 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	58 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized White	75 Participants n=5 Participants	79 Participants n=7 Participants	62 Participants n=5 Participants	67 Participants n=4 Participants	283 Participants n=21 Participants
BMI	29.9 kg/m^2 STANDARD_DEVIATION 6.5 • n=5 Participants	30.3 kg/m^2 STANDARD_DEVIATION 7.3 • n=7 Participants	29.4 kg/m^2 STANDARD_DEVIATION 6.2 • n=5 Participants	30.1 kg/m^2 STANDARD_DEVIATION 8.5 • n=4 Participants	29.9 kg/m^2 STANDARD_DEVIATION 7.1 • n=21 Participants
Hypertension	80 Participants n=5 Participants	81 Participants n=7 Participants	62 Participants n=5 Participants	69 Participants n=4 Participants	292 Participants n=21 Participants
Diabetes mellitus	42 Participants n=5 Participants	40 Participants n=7 Participants	30 Participants n=5 Participants	32 Participants n=4 Participants	144 Participants n=21 Participants
Dyslipidemia	62 Participants n=5 Participants	71 Participants n=7 Participants	52 Participants n=5 Participants	59 Participants n=4 Participants	244 Participants n=21 Participants
Family history of CAD	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	13 Participants n=21 Participants
Aspirin use	88 Participants n=5 Participants	90 Participants n=7 Participants	71 Participants n=5 Participants	70 Participants n=4 Participants	319 Participants n=21 Participants
Oral anticoagulant	9 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	7 Participants n=4 Participants	39 Participants n=21 Participants

PRIMARY outcome

Timeframe: 3 hours

Outcome measures

Outcome measures
Measure	Arm 1 n=96 Participants Standard of care TR Band	Arm 2 n=100 Participants QC/Coban bandage	Arm 3 n=73 Participants QC/Tegaderm dressing	Arm 4 n=86 Participants QC/TR Band
Initial Successful Hemostasis	85 Participants	88 Participants	51 Participants	74 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1 n=96 Participants Standard of care TR Band	Arm 2 n=100 Participants QC/Coban bandage	Arm 3 n=73 Participants QC/Tegaderm dressing	Arm 4 n=86 Participants QC/TR Band
Total Time to Hemostasis	131.5 minutes Standard Deviation 29.8	33.3 minutes Standard Deviation 9.6	10.9 minutes Standard Deviation 20.4	37.2 minutes Standard Deviation 17.3

SECONDARY outcome

Timeframe: 1 hour

RAO will be assessed one hour after completed hemostasis, using the reverse Barbeau's test.

Outcome measures

Outcome measures
Measure	Arm 1 n=96 Participants Standard of care TR Band	Arm 2 n=100 Participants QC/Coban bandage	Arm 3 n=73 Participants QC/Tegaderm dressing	Arm 4 n=86 Participants QC/TR Band
Radial Artery Occlusion (RAO)	5 Participants	4 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 3 hours

The forearm hematoma development is defined according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) classification.

Outcome measures

Outcome measures
Measure	Arm 1 n=96 Participants Standard of care TR Band	Arm 2 n=100 Participants QC/Coban bandage	Arm 3 n=73 Participants QC/Tegaderm dressing	Arm 4 n=86 Participants QC/TR Band
Forearm Hematoma (EASY Classification)	6 Participants	9 Participants	5 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1 n=96 Participants Standard of care TR Band	Arm 2 n=100 Participants QC/Coban bandage	Arm 3 n=73 Participants QC/Tegaderm dressing	Arm 4 n=86 Participants QC/TR Band
Incidence of Pain/Numbness of the Forearm	5 Participants	10 Participants	8 Participants	9 Participants

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jianli Niu

Memorial Healthcare Systerm

Phone: 954-265-6653

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place