Randomized Study of Accelerated Radial Arterial Hemostasis

Hemostasis Clinical Trial

— GOLOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593667
• Other study ID #: WIRB Protocol 20202766
• Secondary ID: 1291856
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: July 14, 2021

Study information

• Verified date: October 2020
• Source: Medcura Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 14, 2021
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemostasis

Intervention

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.

Locations

Country	Name	City	State
United States	Lenox Hill Hospital - Northwell Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Medcura Inc.	Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hemostasis	Significant change in time to hemostasis	60 minutes
Primary	Compressive Force	Change in the compressive force onto the access site	60 minutes
Secondary	Radial Artery	Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test	immediately after hemostasis