Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2015

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: Patent hemostasis
    • Patent hemostasis is the technique for radial artery hemostasis after transradial catheterization, with proactive attempt to maintain radial artery hemostasis and radial artery patency.
  • Active Comparator: Ulnar artery compression
    • Ulnar artery compression will involve radial artery hemostasis using patent hemostasis technique and compression of ulnar artery to the point of occluding flow, in an attempt to augment radial artery flow.

Clinical Trial Outcome Measures

Primary Measures

  • 30 day radial artery occlusion
    • Time Frame: 30 days
    • Evaluation of radial artery patency using plethysmography

Secondary Measures

  • hand ischemia
    • Time Frame: 2 hours
    • evaluated by clinical evaluation for neurosensory deficit or other clinical signs of ischemia.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Total Cardiovascular Solutions
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Samir B Pancholy, MD, Principal Investigator,

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