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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Total Cardiovascular Solutions.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Total Cardiovascular Solutions
ClinicalTrials.gov Identifier:
NCT01564888
First received: March 26, 2012
Last updated: March 27, 2012
Last verified: March 2012
  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 650 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
Radial Artery Occlusion
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.


Estimated Enrollment: 650
Study Start Date: January 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active 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 and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Tejas Patel, MD, DM, FACC 919824030576 tejaspatel@tcvsgroup.org

Locations
India
V.S. General hospital Recruiting
Ahmedabad, Gujarat, India, 380006
Contact: Yash Soni    919824030576    tejaspatel@tcvsgroup.org   
Sub-Investigator: Sanjay Shah, MD, DM         
Sponsors and Collaborators
Total Cardiovascular Solutions
Investigators
Principal Investigator: Samir B Pancholy, MD
  More Information

No publications provided

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: March 27, 2012
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014