Randomized Study of Accelerated Radial Arterial Hemostasis (GOLOW)

Medcura

Status: Completed

Conditions: Hemostasis

Treatments: Device: hm-P bandage

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04593667

1291856 (Other Identifier)

WIRB Protocol 20202766

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Full Inflation

Other group

Description:

100% TR Band inflation relative to recommended inflation with 15-18 cc air injected in TR band bladder

Treatment:

Device: hm-P bandage

Mid Inflation

Other group

Description:

75% TR Band inflation relative to recommended inflation with 11-14 cc air injected in TR band bladder

Treatment:

Device: hm-P bandage

Low Inflation

Other group

Description:

50% TR Band inflation relative to recommended inflation with 8-9 cc air injected in TR band bladder

Treatment:

Device: hm-P bandage