Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Occlusion of Artery Clinical Trial

— PROPHET-II  

Official title:

Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564888
• Other study ID #: MIL/IMRC/TCC/TP/10/2010
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: July 2015

Study information

• Verified date: September 2019
• Source: Total Cardiovascular Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluating the effect of ulnar artery compression while pressing on radial artery to stop bleeding, in maintaining radial artery potency, after cardiac catheterization through the radial artery. We prospectively plan to compare 3000 patients referred for cardiac catheterization, randomized into two groups, one group receiving radial artery compression for stopping bleeding, in a standard fashion following best practices, and the other group receiving radial artery compression using standard best practices and ulnar artery compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure to evaluate its potency, using plethysmography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• patients referred for diagnostic cardiac catheterization.

Exclusion Criteria:

• previous ipsilateral radial artery puncture, warfarin therapy, absence of intact palmar collateral circulation, scleroderma, ipsilateral radial artery surgery, lone upper extremity (contralateral upper extremity amputation), ipsilateral upper extremity chronic pain.

Related Conditions & MeSH terms

• Occlusion of Artery

Intervention

Procedure:
• Ulnar artery compression
Compression of ulnar artery for 2 hours with radial artery hemostasis

Locations

Country	Name	City	State
Czechia	University Hospital and Faculty of Medicine	Pilsen
India	V.S. General hospital	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Total Cardiovascular Solutions

Countries where clinical trial is conducted

Czechia,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day radial artery occlusion	Evaluation of radial artery patency using plethysmography	30 days
Secondary	hand ischemia	evaluated by clinical evaluation for neurosensory deficit or other clinical signs of ischemia.	2 hours