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

NCT02837744 | Completed Results

• 3 other identifiers: ABPL/002U1111-1185-5780CTRI/2016/07/007115
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention; Angiography; Angioplasty

Outcome Measures

Primary Outcomes (1)

• Time to Achieve Hemostasis

  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.

  1 Day

Secondary Outcomes (5)

• Quantity of Product Used

  1 Day

• Number of Patients With Re-bleeding

  1 Day

• Number of Participants With Allergy/Skin Irritation and Hematoma Formation

  Upto 2 Days

• Ease of Use of Product

  Upto 2 Days

• Patient Comfort Level

  1 day

Study Arms (1)

Axiostat®

Size: 3.5 cm X 3.5 cm

Device: Axiostat®

Interventions

Axiostat® DEVICE

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.

Also known as: Hemostatic Dressing

Axiostat®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients who came to the institution/hospital and provided informed consent.

You may qualify if:

• Age greater than or equal to 18 years.
• 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.
• Iatrogenic puncture
• Patient who want to undergo radial intervention.
• All puncture size must be less than 2.5cm.

You may not qualify if:

• Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.).
• Patients with known sensitivity to chitosan (shellfish) used in this study.
• Patients who, in the opinion of the Investigator, may not complete the study for any reason, e.g. Patient requiring Immediate suturing.
• 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.
• Pregnant women.
• Patients with hemorrhagic shock.
• Patient having hemoglobin \< 9 g/dl.

Sponsors & Collaborators

• Axio Biosolutions Pvt. Ltd.: lead

Study Sites (1)

Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola

Ahmedabad, Gujarat, 380060, India

Location

Results Point of Contact

• Title: Shailee Mehta, Clinical Research Manager
• Organization: Axio Biosolutions Pvt. Ltd.

shailee.m@axiobio.com

9879009940

Study Officials

• Milan Chag, Dr.

  Care Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 20, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 11, 2021
• Results First Posted: March 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)