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Completed

NCT Number: NCT04593667

Randomized Study of Accelerated Radial Arterial Hemostasis

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

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Key information

Conditions

Hemostasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lenox Hill Hospital - Northwell Health

New York, 10075, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hm-P bandage

Device

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.

Primary outcomes

  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 outcomes

  1. Radial Artery

    Time frame: immediately after hemostasis

    Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test

Sponsors and collaborators

Lead sponsor

Medcura Inc.

Industry

Collaborators

  • Northwell Health

Registry information

Official study title

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

Acronym: GOLOW

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 20, 2020
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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