- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07621185
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Barcelona, Spania, 08036
- Hospital Clinic of Barcelona
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Eksperimentell: 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.
|
Application of a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol to maintain arterial flow while achieving hemostasis.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Radial Artery Occlusion
Tidsramme: 30 days
|
Radial artery occlusion assessed by absence of distal plethysmographic signal during radial artery compression using the Barbeau test.
|
30 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Local Vascular Complications
Tidsramme: During hospital stay and up to 30 days
|
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
Tidsramme: Immediately after compression
|
Patient-reported pain during the compression period assessed using a visual analog scale (VAS).
|
Immediately after compression
|
|
Total Compression Time
Tidsramme: During procedure
|
Total duration of radial compression measured in minutes from sheath removal to device or dressing removal.
|
During procedure
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Montserrat Pardo, RN, Hospital Clinic of Barcelona
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HCB-RAO-HEMOSTASIS-2022
- HCB/2021/1166 (Annen identifikator: Clinical Research Ethics Committee of Hospital Clínic of Barcelona)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .