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
|Condition or disease||Intervention/treatment||Phase|
|Percutaneous Coronary Intervention||Device: Axiostat® Device: Standard Institutional Care Product||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Size: 3.5 cm X 3.5 cm
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
- 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.
- 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)
- Number of patients with hemostasis
- Number of patients with rebleeding after removal of Axiostat/Standard Institutional Care product
- Quantity of Product used [ Time Frame: 1 Day ]
Number of Axiostat®/ Standard Institutional Care Product required to achieve hemostasis.
Unit of measurement is number.
- 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.
- Ease of use of Product & Patient Comfort Level [ Time Frame: Upto 2 Days ]
- Patients comfort level as assessed by verbal inquiry after completion of procedure.
- Level of ease of use of product (Axiostat®/ Standard Institutional Care Product).
Mode of Measurement is Verbal Inquiry.
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
|Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola|
|Ahmedabad, Gujarat, India, 380060|
|Principal Investigator:||Milan Chag, Dr.||Care Institute of Medical Sciences|