Randomized Study of Accelerated Radial Arterial Hemostasis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04593667

Acronym

GOLOW

Enrollment

Registered

2020-10-20

Start date

2020-11-09

Completion date

2021-07-14

Last updated

2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemostasis

Brief summary

Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (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.

Interventions

DEVICEhm-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

60 patients, randomized into one of three arms

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026