Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial (PROPHET-II)
This study is currently recruiting participants.
Verified March 2012 by Total Cardiovascular Solutions
Sponsor:
Total Cardiovascular Solutions
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
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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
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 May 21, 2013