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Completed

NCT Number: NCT01564888

Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

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.

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Key information

Conditions

Occlusion of Artery Arterial Occlusive Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital and Faculty of Medicine, Pilsen, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ulnar artery compression

Procedure

Compression of ulnar artery for 2 hours with radial artery hemostasis

Primary outcomes

  1. 30 day radial artery occlusion

    Time frame: 30 days

    Evaluation of radial artery patency using plethysmography

Secondary outcomes

  1. hand ischemia

    Time frame: 2 hours

    evaluated by clinical evaluation for neurosensory deficit or other clinical signs of ischemia.

Sponsors and collaborators

Lead sponsor

Total Cardiovascular Solutions

Other

Registry information

Acronym: PROPHET-II

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2012
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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