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Completed

NCT Number: NCT02837744

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ahmedabad, Gujarat, 380060, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Hemostatic Dressing

Primary outcomes

  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.

Secondary outcomes

  1. Quantity of Product Used

    Time frame: 1 Day

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

  2. Number of Patients With Re-bleeding

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Axio Biosolutions Pvt. Ltd.

Other

Registry information

Official study title

Safety and Efficacy of Axiostat® Hemostatic Dressing on Radial Access After Percutaneous Procedure

Acronym: AHD

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2016
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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