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Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01564888
Acronym
PROPHET-II
Enrollment
3000
Registered
2012-03-28
Start date
2011-01-31
Completion date
2015-07-31
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occlusion of Artery

Brief 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.

Interventions

PROCEDUREUlnar artery compression

Compression of ulnar artery for 2 hours with radial artery hemostasis

Sponsors

Total Cardiovascular Solutions
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
30 day radial artery occlusion30 daysEvaluation of radial artery patency using plethysmography

Secondary

MeasureTime frameDescription
hand ischemia2 hoursevaluated by clinical evaluation for neurosensory deficit or other clinical signs of ischemia.

Countries

Czechia, India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026