Manual vs Pneumatic Compression to Prevent Radial Artery Occlusion After Transradial Procedures (RADIAL-HEMO)

Manual Radial Compression Versus Gradual Pneumatic Compression for the Prevention of Radial Artery Occlusion After Transradial Cardiac Catheterization: A Pragmatic Multicenter Study

This study evaluates two commonly used methods of achieving hemostasis after transradial cardiac catheterization: manual compression and pneumatic compression with gradual deflation.

Transradial access is widely used for diagnostic and interventional cardiac procedures due to its safety profile, but radial artery occlusion remains a relevant complication that may limit future vascular access.

In this pragmatic, prospective, multicenter study conducted in routine clinical practice, adult patients undergoing transradial cardiac catheterization were assigned to receive either manual compression or pneumatic compression using a standardized patent hemostasis protocol. The primary objective is to compare the incidence of radial artery occlusion at 30 days between both strategies.

Secondary outcomes include local vascular complications, patient-reported pain, and total compression time.

Study Overview

• Status: Completed
• Conditions: Cardiac Catheterization; Radial Artery Occlusion
• Intervention / Treatment: Procedure: Manual Radial Compression; Device: Pneumatic Radial Compression Device

Detailed Description

Transradial access has become the preferred approach for diagnostic and interventional coronary procedures due to its association with reduced bleeding complications, earlier mobilization, and shorter hospital stay compared with transfemoral access. However, radial artery occlusion (RAO) remains a relevant access-site complication that may limit future vascular access or the use of the radial artery as a conduit for coronary artery bypass grafting.

Hemostasis following radial sheath removal is a critical step in preserving arterial patency. Two commonly used strategies include manual compression using sterile gauze and non-circumferential adhesive dressing, and pneumatic compression using dedicated mechanical devices typically applied with gradual deflation protocols. Both approaches aim to achieve effective hemostasis while maintaining antegrade arterial flow, a concept known as patent hemostasis.

This study was designed as a pragmatic, prospective, multicenter interventional study conducted across eight hospitals in Spain, with central coordination from Hospital Clinic of Barcelona. The objective was to compare the effectiveness and safety of manual radial compression versus pneumatic compression with gradual deflation under standardized patent hemostasis protocols in real-world clinical practice.

Consecutive adult patients undergoing diagnostic or interventional cardiac catheterization via transradial access were included. After sheath removal, participants were assigned in a 1:1 predefined alternating sequence to either manual compression or pneumatic compression strategies.

In the manual compression group, hemostasis was achieved using direct pressure with sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency assessed by plethysmography. In the pneumatic compression group, a dedicated compression device was applied and gradually deflated according to a standardized protocol to achieve patent hemostasis.

The primary outcome was radial artery occlusion at 30 days, defined as absence of distal plethysmographic signal during radial artery compression assessed using the Barbeau test. Secondary outcomes included local vascular complications (such as hematoma, persistent bleeding, or pseudoaneurysm), patient-reported pain assessed using a visual analog scale (VAS), and total compression time.

All participating centers followed a unified protocol, and hemostasis procedures were performed by trained nursing staff. The study was designed to reflect routine clinical practice conditions and to evaluate whether clinical outcomes are primarily influenced by the type of compression strategy or by the standardized implementation of patent hemostasis protocols.

• Study Type: Interventional
• Enrollment (Actual): 1168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged ≥18 years
• Undergoing diagnostic or interventional cardiac catheterization via transradial access
• Preserved dual hand circulation confirmed by Barbeau test
• Ability to provide informed consent
• Ability to complete 30-day follow-up

Exclusion Criteria:

• Refusal to participate
• Inability to complete follow-up
• Abnormal collateral circulation (Barbeau type D)
• Initial failure of radial access
• Contraindication to prolonged radial compression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Compression; Hemostasis achieved by direct manual compression using sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency. Compression duration was approximately 3-4 hours depending on the procedure.	Procedure: Manual Radial Compression; Direct manual compression using sterile gauze and a non-circumferential adhesive dressing applied after radial sheath removal, with progressive pressure adjustment to achieve patent hemostasis.
Experimental: Pneumatic Compression; Hemostasis achieved using a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol, ensuring bleeding control while maintaining arterial flow. The device was progressively deflated until complete removal.	Device: Pneumatic Radial Compression Device; Application of a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol to maintain arterial flow while achieving hemostasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery Occlusion	Radial artery occlusion assessed by absence of distal plethysmographic signal during radial artery compression using the Barbeau test.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Vascular Complications	Incidence of access-site complications including hematoma, persistent bleeding, pseudoaneurysm, or other local vascular complications.	During hospital stay and up to 30 days
Pain During Compression	Patient-reported pain during the compression period assessed using a visual analog scale (VAS).	Immediately after compression
Total Compression Time	Total duration of radial compression measured in minutes from sheath removal to device or dressing removal.	During procedure

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Montserrat Pardo, RN, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): November 27, 2024

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Interventional Cardiology; Pneumatic Compression Device; Transradial Access; Manual Compression; Patent Hemostasis; Radial Compression
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: HCB-RAO-HEMOSTASIS-2022; HCB/2021/1166 (Other Identifier: Clinical Research Ethics Committee of Hospital Clínic of Barcelona)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No