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Randomized Study of Accelerated Radial Arterial Hemostasis (GOLOW)

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: NCT04593667
Recruitment Status : Completed
First Posted : October 20, 2020
Last Update Posted : September 8, 2021
Sponsor:
Collaborator:
Northwell Health
Information provided by (Responsible Party):
Medcura Inc.

Study Description
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Brief Summary:
Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage

Condition or disease Intervention/treatment Phase
Hemostasis Device: hm-P bandage Not Applicable

Detailed Description:
The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, & N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 60 patients, randomized into one of three arms
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Utilizing a Novel Agent in a Randomized Study of Accelerated Radial Arterial Hemostasis Under Reduced Compression Following Percutaneous Transradial Coronary Angiography/Intervention
Actual Study Start Date : November 9, 2020
Actual Primary Completion Date : December 9, 2020
Actual Study Completion Date : July 14, 2021
Arms and Interventions
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Arm Intervention/treatment
Full Inflation
100% TR Band inflation relative to recommended inflation with 15-18 cc air injected in TR band bladder
 Device: hm-P bandage
hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.
Mid Inflation
75% TR Band inflation relative to recommended inflation with 11-14 cc air injected in TR band bladder
 Device: hm-P bandage
hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.
Low Inflation
50% TR Band inflation relative to recommended inflation with 8-9 cc air injected in TR band bladder
 Device: hm-P bandage
hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.


Outcome Measures
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Primary Outcome Measures :
  1. Time to hemostasis [ Time Frame: 60 minutes ]
    Significant change in time to hemostasis

  2. Compressive Force [ Time Frame: 60 minutes ]
    Change in the compressive force onto the access site


Secondary Outcome Measures :
  1. Radial Artery [ Time Frame: immediately after hemostasis ]
    Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test


Eligibility Criteria
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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:

  • Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention.

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT04593667


Locations
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United States, New York
Lenox Hill Hospital - Northwell Health
New York, New York, United States, 10075
Sponsors and Collaborators
Medcura Inc.
Northwell Health
Investigators
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Principal Investigator: Varinder Singh, MD Northwell Health
More Information
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Responsible Party: Medcura Inc.
ClinicalTrials.gov Identifier: NCT04593667    
Other Study ID Numbers: WIRB Protocol 20202766
1291856 ( Other Identifier: WIRB )
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No