Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial (PROPHET-II)

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 Overview

• Status: Completed
• Conditions: Occlusion of Artery
• Intervention / Treatment: Procedure: Ulnar artery compression

• Study Type: Interventional
• Enrollment (Actual): 3000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czechia
  • Pilsen, Czechia
    • University Hospital and Faculty of Medicine
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380006
      • V.S. General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Ulnar artery compression; Compression of ulnar artery for 2 hours with radial artery hemostasis
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.	Procedure: Ulnar artery compression; Compression of ulnar artery for 2 hours with radial artery hemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day radial artery occlusion	Evaluation of radial artery patency using plethysmography	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hand ischemia	evaluated by clinical evaluation for neurosensory deficit or other clinical signs of ischemia.	2 hours

Collaborators and Investigators

• Sponsor: Total Cardiovascular Solutions
• Investigators: Principal Investigator: Samir B Pancholy, MD

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 26, 2012
• First Posted (ESTIMATE): March 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 14, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MIL/IMRC/TCC/TP/10/2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO