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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Total Cardiovascular Solutions
ClinicalTrials.gov Identifier:
NCT01564888
First received: March 26, 2012
Last updated: February 16, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Occlusion of Artery
Procedure: Ulnar artery compression
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Further study details as provided by Total Cardiovascular Solutions:

Primary Outcome Measures:
  • 30 day radial artery occlusion [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Evaluation of radial artery patency using plethysmography


Secondary Outcome Measures:
  • hand ischemia [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    evaluated by clinical evaluation for neurosensory deficit or other clinical signs of ischemia.


Enrollment: 3000
Study Start Date: January 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01564888

Locations
India
V.S. General hospital
Ahmedabad, Gujarat, India, 380006
Sponsors and Collaborators
Total Cardiovascular Solutions
Investigators
Principal Investigator: Samir B Pancholy, MD
  More Information

Responsible Party: Total Cardiovascular Solutions
ClinicalTrials.gov Identifier: NCT01564888     History of Changes
Other Study ID Numbers: MIL/IMRC/TCC/TP/10/2010 
Study First Received: March 26, 2012
Last Updated: February 16, 2016
Health Authority: India: Indian Council of Medical Research
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on July 21, 2016