GOLOW: Randomized Study of Accelerated Radial Arterial Hemostasis

Sponsor

Medcura Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04593667

Collaborator

Northwell Health (Other)

Enrollment

Location

Arms

8.1

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

60 patients, randomized into one of three arms60 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 :

Nov 9, 2020

Actual Primary Completion Date :

Dec 9, 2020

Actual Study Completion Date :

Jul 14, 2021

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

Time to hemostasis [60 minutes]
Significant change in time to hemostasis
Compressive Force [60 minutes]
Change in the compressive force onto the access site

Secondary Outcome Measures

Radial Artery [immediately after hemostasis]
Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Lenox Hill Hospital - Northwell Health	New York	New York	United States	10075

Sponsors and Collaborators

Medcura Inc.
Northwell Health

Investigators

Principal Investigator: Varinder Singh, MD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medcura Inc.

ClinicalTrials.gov Identifier:

NCT04593667

Other Study ID Numbers:

WIRB Protocol 20202766
1291856

First Posted:

Oct 20, 2020

Last Update Posted:

Sep 8, 2021

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Sep 8, 2021