Randomized Study of Accelerated Radial Arterial Hemostasis (GOLOW)

Utilizing a Novel Agent in a Randomized Study of Accelerated Radial Arterial Hemostasis Under Reduced Compression Following Percutaneous Transradial Coronary Angiography/Intervention

Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage

Study Overview

• Status: Completed
• Conditions: Hemostasis
• Intervention / Treatment: Device: hm-P bandage

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital - Northwell Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to hemostasis	Significant change in time to hemostasis	60 minutes
Compressive Force	Change in the compressive force onto the access site	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery	Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test	immediately after hemostasis

Collaborators and Investigators

• Sponsor: Medcura Inc.
• Collaborators: Northwell Health
• Investigators: Principal Investigator: Varinder Singh, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2020
• Primary Completion (ACTUAL): December 9, 2020
• Study Completion (ACTUAL): July 14, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: WIRB Protocol 20202766; 1291856 (OTHER: WIRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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