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

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ClinicalTrials.gov Identifier: NCT02837744
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Axio Biosolutions Pvt. Ltd.

Brief Summary:
To evaluate Safety and Efficacy of Axiostat® hemostatic dressing as compared to Standard Institutional Care product in terms of time to achieve hemostasis, post application complication and comfort levels of patients.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Device: Axiostat® Device: Standard Institutional Care Product Not Applicable

Detailed Description:
To evaluate Safety and Efficacy of Axiostat® hemostatic dressing as compared to Standard Institutional Care product in terms of time to achieve hemostasis, post application complication and comfort levels of patients who have undergone radial intervention.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure : A Comparative Open Label Study
Study Start Date : September 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Axiostat®
Size: 3.5 cm X 3.5 cm
Device: Axiostat®

Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site.

Axiostat® stops moderate to severe bleeding due to cuts, abrasions, lacerations, venous/arterial punctures and more. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the wound area.

Other Name: Hemostatic Dressing

Active Comparator: Standard Institutional Care Product
Radial band: Size - 24 cm X 4 cm; Cotton Gauze: Size - 5 x 5 cm
Device: Standard Institutional Care Product
Band Size: 24 x 4 cm Cotton Gauze size : 5 x 5 cm
Other Name: Band / Cotton Gauze




Primary Outcome Measures :
  1. Time to achieve hemostasis [ Time Frame: 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:seconds.


  2. Number of patients with hemostasis;number of patients with rebleeding [ Time Frame: 1 Day ]

    Number of patients will be counted (unit of measurement is number/count of patients)

    1. Number of patients with hemostasis
    2. Number of patients with rebleeding after removal of Axiostat/Standard Institutional Care product

  3. Quantity of Product used [ Time Frame: 1 Day ]

    Number of Axiostat®/ Standard Institutional Care Product required to achieve hemostasis.

    Unit of measurement is number.



Secondary Outcome Measures :
  1. Skin Irritation & & Formation of Hematoma [ Time Frame: Upto 2 Days ]

    (1)Observing Allergy/Skin Irritation because of Axiostat®/ Standard Institutional Care Product.

    (2))Observation of formation of Hematoma and/or any vascular complication after removal of Axiostat®/ Standard Institutional Care Product.

    Mode of Measurement is Visual Observation.


  2. Ease of use of Product & Patient Comfort Level [ Time Frame: Upto 2 Days ]
    1. Patients comfort level as assessed by verbal inquiry after completion of procedure.
    2. Level of ease of use of product (Axiostat®/ Standard Institutional Care Product).

    Mode of Measurement is Verbal Inquiry.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837744


Locations
India
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

Responsible Party: Axio Biosolutions Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02837744     History of Changes
Other Study ID Numbers: ABPL/002
U1111-1185-5780 ( Other Identifier: World Health Organization )
CTRI/2016/07/007115 ( Registry Identifier: Clinical Trial Registry - India )
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hemostatics
Coagulants