Trial Outcomes & Findings for Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure (NCT NCT02837744)

NCT ID: NCT02837744

Last Updated: 2021-03-11

Results Overview

Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops. Unit of measurement is minutes.

• Recruitment status: COMPLETED
• Target enrollment: 70 participants
• Primary outcome timeframe: 1 Day
• Results posted on: 2021-03-11

Participant Flow

Participant milestones

Measure	Axiostat® Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
Overall Study STARTED	70
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Males and Females have been mentioned separately

Baseline characteristics by cohort

Measure	Axiostat® n=70 Participants Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
Age, Continuous Males	55.94 years STANDARD_DEVIATION 12.23 • n=53 Participants • Males and Females have been mentioned separately
Age, Continuous Females	56.35 years STANDARD_DEVIATION 9.17 • n=17 Participants • Males and Females have been mentioned separately
Sex: Female, Male Female	17 Participants n=70 Participants
Sex: Female, Male Male	53 Participants n=70 Participants
Region of Enrollment India	70 Participants n=70 Participants
Body Mass Index	28.27 kg/m^2 STANDARD_DEVIATION 6.29 • n=70 Participants
Baseline Blood Pressure Systolic Blood Pressure	136 mmHg STANDARD_DEVIATION 20 • n=70 Participants
Baseline Blood Pressure Diastolic Blood Pressure	81 mmHg STANDARD_DEVIATION 13 • n=70 Participants
Haemoglobin	13.4 g/dl STANDARD_DEVIATION 1.37 • n=70 Participants
Prior History and Risk Factors Diabetes	24 Participants n=70 Participants
Prior History and Risk Factors Hypertension	41 Participants n=70 Participants
Prior History and Risk Factors Prior Percutaneous Coronary Intervention	3 Participants n=70 Participants
Prior History and Risk Factors Hyperlipidemia	2 Participants n=70 Participants
Prior History and Risk Factors Smoking	2 Participants n=70 Participants
Prior History and Risk Factors Prior Myocardial Infarction	1 Participants n=70 Participants
Prior History and Risk Factors Prior Coronary Artery Bypass Graft	1 Participants n=70 Participants
Prior History and Risk Factors Cardiogenic Shock	1 Participants n=70 Participants

PRIMARY outcome

Timeframe: 1 Day

Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.

Unit of measurement is minutes.

Outcome measures

Measure	Axiostat® n=70 Participants Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
Time to Achieve Hemostasis	5.43 minutes Standard Deviation 1.36

SECONDARY outcome

Timeframe: 1 Day

Number of Axiostat® required to achieve hemostasis. Unit of measurement is number.

Outcome measures

Measure	Axiostat® n=70 Participants Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
Quantity of Product Used	1 unit

SECONDARY outcome

Timeframe: 1 Day

Number of patients will be counted (unit of measurement is number/count of patients) with re-bleeding after removal of Axiostat

Outcome measures

Measure	Axiostat® n=70 Participants Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
Number of Patients With Re-bleeding	1 Participants

SECONDARY outcome

Timeframe: Upto 2 Days

1. Observing occurrence of Allergy/Skin Irritation at the puncture site

2. Observation of formation of Hematoma and/or any vascular complication after removal of Axiostat®.

Mode of Measurement for both of the above outcomes is Visual Observation.

Skin irritation/Allergy: Occurrence of redness at the puncture site was noted as skin irritation/allergy Hematoma: Hematoma formation at the puncture site. Hematoma was defined as presence of ecchymosis (the escape of blood into the tissues from ruptured blood vessels) at access site.

Outcome measures

Measure	Axiostat® n=70 Participants Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
Number of Participants With Allergy/Skin Irritation and Hematoma Formation	0 Participants

SECONDARY outcome

Timeframe: Upto 2 Days

Level of ease of use of Axiostat was recorded. The ease of application and removal of Axiostat was rated as Excellent or Good or Fair or Poor by the Clinician / Operator Mode of Measurement is Verbal Inquiry.

Outcome measures

Measure	Axiostat® n=70 Participants Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
Ease of Use of Product Application · Excellent	15 Participants
Ease of Use of Product Application · Good	52 Participants
Ease of Use of Product Application · Fair	3 Participants
Ease of Use of Product Removal · Excellent	13 Participants
Ease of Use of Product Removal · Good	57 Participants
Ease of Use of Product Removal · Fair	0 Participants

SECONDARY outcome

Timeframe: 1 day

Patients comfort level for use of dressing was recorded. The patient was required to rate the comfort level of use of dressing in terms of pain and swelling at the puncture site.

It was assessed by verbal inquiry and visual observation.

Outcome measures

Measure	Axiostat® n=70 Participants Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
Patient Comfort Level No swelling & pain	59 Participants
Patient Comfort Level Minor swelling & pain	11 Participants
Patient Comfort Level Tolerable swelling & pain	0 Participants
Patient Comfort Level Intolerable swelling & pain	0 Participants

Adverse Events

Axiostat®

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

Shailee Mehta, Clinical Research Manager

Axio Biosolutions Pvt. Ltd.

Phone: 9879009940

Email: shailee.m@axiobio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place