Randomized Study of Accelerated Radial Arterial Hemostasis

Not Applicable

Completed

• Conditions: Hemostasis
• Interventions: Device: hm-P bandage

• Registration Number: NCT04593667
• Lead Sponsor: Medcura Inc.

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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Study Start: 2020-11-09
• Primary Completion: 2020-12-09
• Study Completion: 2021-07-14
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mid Inflation	hm-P bandage	75% TR Band inflation relative to recommended inflation with 11-14 cc air injected in TR band bladder
Low Inflation	hm-P bandage	50% TR Band inflation relative to recommended inflation with 8-9 cc air injected in TR band bladder
Full Inflation	hm-P bandage	100% TR Band inflation relative to recommended inflation with 15-18 cc air injected in TR band bladder

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Radial Artery	immediately after hemostasis	Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test

Trial Locations

Locations (1)

Lenox Hill Hospital - Northwell Health; 🇺🇸 New York, New York, United States