AHD: Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure

• Sponsor: Axio Biosolutions Pvt. Ltd. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02837744
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Actual Duration (Months): 14
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Coronary Intervention; Angiography; Angioplasty	Device: Axiostat®

Detailed Description

To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients who have undergone radial intervention.

Study Design

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Axiostat® Size: 3.5 cm X 3.5 cm	Device: Axiostat®; 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.; Other Names: Hemostatic Dressing

Outcome Measures

Primary Outcome Measures

1. Time to Achieve Hemostasis [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.

Secondary Outcome Measures

1. Quantity of Product Used [1 Day]

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

2. Number of Patients With Re-bleeding [1 Day]

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

3. Number of Participants With Allergy/Skin Irritation and Hematoma Formation [Upto 2 Days]

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

4. Ease of Use of Product [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.

5. Patient Comfort Level [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age greater than or equal to 18 years.

2. Patient and/or patient's legal representative and/or impartial witness has/have been informed of the nature of the study and agrees to its provision and has provided written informed consent as approved by the Ethics Committee of the investigative site.

3. Iatrogenic puncture

4. Patient who want to undergo radial intervention.

5. All puncture size must be less than 2.5cm.

Exclusion Criteria:

1. Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.).

2. Patients with known sensitivity to chitosan (shellfish) used in this study.

3. Patients who, in the opinion of the Investigator, may not complete the study for any reason, e.g. Patient requiring Immediate suturing.

4. Patient is currently participating in an investigational drug or dressing study that has not yet completed its primary endpoint interferes with procedure and assessments in this trial.

5. Pregnant women.

6. Patients with hemorrhagic shock.

7. Patient having hemoglobin < 9 g/dl.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola	Ahmedabad	Gujarat	India	380060

Sponsors and Collaborators

• Axio Biosolutions Pvt. Ltd.

Investigators

• Principal Investigator: Milan Chag, Dr., Care Institute of Medical Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 31, 2020

More Information

Publications

None provided.

• Responsible Party: Axio Biosolutions Pvt. Ltd.
• ClinicalTrials.gov Identifier: NCT02837744
• Other Study ID Numbers: ABPL/002; U1111-1185-5780; CTRI/2016/07/007115
• First Posted: Jul 20, 2016
• Last Update Posted: Mar 11, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hemostatics

Study Results

Participant Flow

Arm/Group Title	Axiostat®
Arm/Group Description	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.
Period Title: Overall Study
STARTED	70
COMPLETED	70
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Axiostat®
Arm/Group Description	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 Participants	70
Age (years) [Mean (Standard Deviation) ]
Males	55.94 (12.23)
Females	56.35 (9.17)
Sex: Female, Male (Count of Participants)
Female	17 24.3%
Male	53 75.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
India	70 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.27 (6.29)
Baseline Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Systolic Blood Pressure	136 (20)
Diastolic Blood Pressure	81 (13)
Haemoglobin (g/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dl]	13.4 (1.37)
Prior History and Risk Factors (Count of Participants)
Diabetes	24 34.3%
Hypertension	41 58.6%
Prior Percutaneous Coronary Intervention	3 4.3%
Hyperlipidemia	2 2.9%
Smoking	2 2.9%
Prior Myocardial Infarction	1 1.4%
Prior Coronary Artery Bypass Graft	1 1.4%
Cardiogenic Shock	1 1.4%

Outcome Measures

1. Primary Outcome

Title	Time to Achieve Hemostasis
Description	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.
Time Frame	1 Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Axiostat®
Arm/Group Description	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.
Measure Participants	70
Mean (Standard Deviation) [minutes]	5.43 (1.36)

2. Secondary Outcome

Title	Quantity of Product Used
Description	Number of Axiostat® required to achieve hemostasis. Unit of measurement is number.
Time Frame	1 Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Axiostat®
Arm/Group Description	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.
Measure Participants	70
Number [unit]	1

3. Secondary Outcome

Title	Number of Patients With Re-bleeding
Description	Number of patients will be counted (unit of measurement is number/count of patients) with re-bleeding after removal of Axiostat
Time Frame	1 Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Axiostat®
Arm/Group Description	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.
Measure Participants	70
Count of Participants [Participants]	1 1.4%

4. Secondary Outcome

Title	Number of Participants With Allergy/Skin Irritation and Hematoma Formation
Description	Observing occurrence of Allergy/Skin Irritation at the puncture site 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.
Time Frame	Upto 2 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Axiostat®
Arm/Group Description	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.
Measure Participants	70
Count of Participants [Participants]	0 0%

5. Secondary Outcome

Title	Ease of Use of Product
Description	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.
Time Frame	Upto 2 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Axiostat®
Arm/Group Description	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.
Measure Participants	70
Excellent	15 21.4%
Good	52 74.3%
Fair	3 4.3%
Excellent	13 18.6%
Good	57 81.4%
Fair	0 0%

6. Secondary Outcome

Title	Patient Comfort Level
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Axiostat®
Arm/Group Description	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.
Measure Participants	70
No swelling & pain	59 84.3%
Minor swelling & pain	11 15.7%
Tolerable swelling & pain	0 0%
Intolerable swelling & pain	0 0%

Adverse Events

Time Frame	Adverse event data was collected till the patient was discharged.
Adverse Event Reporting Description	Any occurrence of adverse event was be recorded on the Adverse Event CRF. The number of patients at risk of adverse event is minimum as the product under evaluation is an approved product and so associated risks are less.
Arm/Group Title	Axiostat®
Arm/Group Description	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.
All Cause Mortality
	Axiostat®
	Affected / at Risk (%)	# Events
Total	0/70 (0%)
Serious Adverse Events
	Axiostat®
	Affected / at Risk (%)	# Events
Total	0/70 (0%)
Other (Not Including Serious) Adverse Events
	Axiostat®
	Affected / at Risk (%)	# Events
Total	0/70 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.