RAPHE: Radial Artery Puncture Hemostasis Study

• Sponsor: Semmelweis University Heart and Vascular Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04857385
• Collaborator: (none)
• Enrollment: 600
• Locations: 3
• Arms: 3
• Anticipated Duration (Months): 20.6
• Patients Per Site: 200
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization.

A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices.

Follow-up of the subject will take place 60 days after the index procedure.

Condition or Disease	Intervention/Treatment	Phase
Radial Artery Hemostasis	Device: Radial artery hemostasis	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Radial Artery Puncture Hemostasis: Physical, Biological and Chemical Methods
• Actual Study Start Date: Apr 14, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Terumo TR Band Physical standard of care radial hemostasis device.	Device: Radial artery hemostasis; Each of the devices will be assessed for radial artery hemostasis.
Experimental: StatSeal Potassium-ferrate based chemical hemostasis device.	Device: Radial artery hemostasis; Each of the devices will be assessed for radial artery hemostasis.
Experimental: Axiostat Chitosan based biological hemostasis device.	Device: Radial artery hemostasis; Each of the devices will be assessed for radial artery hemostasis.

Outcome Measures

Primary Outcome Measures

1. Radial artery occlusion [24 hours post-procedure or at hospital discharge (whichever comes first)]

   Frequency of radial artery occlusion after hemostasis

2. Radial artery occlusion [60 days (+/-10 days) post-procedure]

   Frequency of radial artery occlusion after hemostasis

3. Radial artery (pseudo)aneurysm formation [24 hours post-procedure or at hospital discharge (whichever comes first)]

   Frequency of radial artery (pseudo)aneurysm formation after hemostasis

4. Radial artery (pseudo)aneurysm formation [60 days (+/-10 days) post-procedure]

   Frequency of radial artery (pseudo)aneurysm formation after hemostasis

5. Radial artery fistula formation [24 hours post-procedure or at hospital discharge (whichever comes first)]

   Frequency of radial artery arteriovenous fistula formation after hemostasis

6. Radial artery fistula formation [60 days (+/-10 days) post-procedure]

   Frequency of radial artery arteriovenous fistula formation after hemostasis

7. Radial artery bleeding [24 hours post-procedure or at hospital discharge (whichever comes first)]

   Bleeding from the radial artery puncture, classified via the EASY method

8. Radial artery bleeding [60 days (+/-10 days) post-procedure]

   Bleeding from the radial artery puncture, classified via the EASY method

Secondary Outcome Measures

1. Initial compression time of hemostatsis device [Up to 30 minutes post-procedure]

   Initial time (in minutes) of the hemostasis device, needed to achieve primary patent hemostasis

2. Overall compression time [Up to 24 hours post-procedure]

   Overall time (in minutes) of device use as a hemostatis tool

3. Number of compression devices needed [Up to 24 hours post-procedure]

   Overall number of compression devices needed for hemostatis

Other Outcome Measures

1. Need for bail-out device [Up to 24 hours post-procedure]

   Percentage of patients requiring bail-out hemostasis devices

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Coronary angiogram planned from a radial artery approach

• Use of 5, 6 or 7 French sheaths

Exclusion Criteria:

• Radial artery diameter <1.8 mm as measured via ultrasound

• Established peripheral arterial disease

• Known autoimmune illness

• Hemodynamic instability

• Pregnant or nursing

• Condition following resuscitation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Szeged, Department of Invasive Cardiology	Szeged	Csongád-Csanád	Hungary	6725
2	Department of Cardiology and Cardiac Surgery	Debrecen	Hajdú-Bihar	Hungary	4032
3	Semmelweis University Heart and Vascular Center	Budapest		Hungary	1122

Sponsors and Collaborators

• Semmelweis University Heart and Vascular Center

Investigators

• Principal Investigator: István F Édes, MD PhD, Semmelweis Univeristy Heart and Vascular Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kulyassa P, Németh BT, Ehrenberger R, Ruzsa Z, Szük T, Fehérvári P, Engh MA, Becker D, Merkely B, Édes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022.

• Responsible Party: Istvan Edes, Associate Professor, Semmelweis University Heart and Vascular Center
• ClinicalTrials.gov Identifier: NCT04857385
• Other Study ID Numbers: RAPHE-001
• First Posted: Apr 23, 2021
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Istvan Edes, Associate Professor, Semmelweis University Heart and Vascular Center: Radial artery puncture; Radial artery occlusion; Radial artery bleeding
• Additional relevant MeSH terms: Hemostatics

Study Results

No Results Posted as of Jun 30, 2022