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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01564888
First Posted: March 28, 2012
Last Update Posted: February 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Total Cardiovascular Solutions
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Evaluation of radial artery patency using plethysmography


Secondary Outcome Measures:
  • hand ischemia [ Time Frame: 2 hours ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 26, 2012
First Posted: March 28, 2012
Last Update Posted: February 18, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hemostatics
Coagulants


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