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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837744
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Axio Biosolutions Pvt. Ltd.

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
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.

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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 : September 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Group/Cohort Intervention/treatment
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.
Other Name: Hemostatic Dressing




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

  3. Quantity of Product used [ Time Frame: 1 Day ]
    Number of Axiostat® 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 (2))Observation of formation of Hematoma and/or any vascular complication after removal of Axiostat®.

    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. 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
Sampling Method:   Non-Probability Sample
Study Population
All eligible patients who came to the institution/hospital and provided informed consent.
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
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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
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Principal Investigator: Milan Chag, Dr. Care Institute of Medical Sciences
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Responsible Party: Axio Biosolutions Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02837744    
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: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hemostatics
Coagulants