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A-priori Versus Provisional Heparin on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis (PHARAOH)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Patent hemostasis and heparin
Sponsored by
Olivier F. Bertrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring radial artery occlusion, hemostasis, coronary intervention, radial approach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all diagnostic cardiac cath patients

Exclusion Criteria:

  • warfarin therapy
  • previous ipsilateral TRA
  • lack of consent
  • abnormal (type D) Barbeau test
  • scleroderma
  • thrombocytopenia
  • or other contraindications to heparin

Sites / Locations

  • Commonwealth Medical College,
  • IUCPQ
  • Sheth VS General Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Compression without adjustment

Patent hemostasis & heparin

Arm Description

TR band (Terumo medical) applied. The TR band is then deflated gradually till pulsatile bleeding is observed under the transparent plastic inflatable chamber and then 1-2 cc of air is placed back in the TR band chamber to stop bleeding. The band is left in place for 2 hours and not adjusted further unless patient complained of symptoms or bleeding occurred.

TR-band is placed and positioned similarly to the other study arm. However, in theses cases, patency is evaluated at the time of application of the TR-band, and monitored every 15 minutes afterwards till the band is removed and hemostasis completed. After TR-band placement, if maintenance of radial artery patency is obtained, no heparin is administered and TR band is left in place for 1-hour. If radial artery patency is not maintained, a bolus of heparin 50 U/kg or a maximum of 5000 units is administered and the band is left in place for 2 hours.

Outcomes

Primary Outcome Measures

Radial artery occlusion
Plethysmography, confirmed with duplex Doppler ultrasonography

Secondary Outcome Measures

Radial artery occlusion
Plethysmography, confirmed with duplex Doppler ultrasonography

Full Information

First Posted
December 1, 2011
Last Updated
May 7, 2012
Sponsor
Olivier F. Bertrand
Collaborators
Community Medical Center, Scranton, PA, Sheth Vadilal Sarabhai General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01489917
Brief Title
A-priori Versus Provisional Heparin on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis
Acronym
PHARAOH
Official Title
Comparison of A-priori Versus Provisional Heparin Therapy on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olivier F. Bertrand
Collaborators
Community Medical Center, Scranton, PA, Sheth Vadilal Sarabhai General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Provisional Heparin TherApy on Radial Artery Occlusion after transradial coronary angiography and patent Hemostasis (PHARAOH) study compares the strategy of standard a-priori heparin use in patients undergoing transradial coronary angiography to a strategy of provisional heparin administration only if patent hemostasis is not achievable.
Detailed Description
Transradial access use for coronary angiography and intervention is increasing. Its efficacy in lowering access site complications, as well as increased patient comfort, has been proven unequivocally. One of the complications of transradial access is radial artery occlusion (RAO) that occurs with a variable incidence. It is population specific, with a higher prevalence in subsets, such as women, and patient's with small radial arteries. RAO is also known to be higher at hospital discharge and radial recanalization may spontaneously occur at later times. It is usually asymptomatic. Its main adverse impact is by limiting future transradial access from that radial artery. Since most of the patient's with atherosclerotic vascular disease may undergo several invasive procedures during their lifetime, prevention of RAO is of paramount importance. Heparinization, during the procedure, has been shown to be of benefit in lowering the incidence of RAO. Maintaining patency of the radial artery during hemostasis, has also been shown to be effective in prevention of RAO following transradial access. As maintenance of flow has potent antithrombotic effect, it is unclear whether systemic anticoagulation is still required in all cases. In some cases, it would be preferable to avoid heparin administration prior to coronary angiography. It is currently unknown whether it would be safe to refrain from heparin administration in case of transradial catheterization and patent hemostasis technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
radial artery occlusion, hemostasis, coronary intervention, radial approach

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
428 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compression without adjustment
Arm Type
No Intervention
Arm Description
TR band (Terumo medical) applied. The TR band is then deflated gradually till pulsatile bleeding is observed under the transparent plastic inflatable chamber and then 1-2 cc of air is placed back in the TR band chamber to stop bleeding. The band is left in place for 2 hours and not adjusted further unless patient complained of symptoms or bleeding occurred.
Arm Title
Patent hemostasis & heparin
Arm Type
Experimental
Arm Description
TR-band is placed and positioned similarly to the other study arm. However, in theses cases, patency is evaluated at the time of application of the TR-band, and monitored every 15 minutes afterwards till the band is removed and hemostasis completed. After TR-band placement, if maintenance of radial artery patency is obtained, no heparin is administered and TR band is left in place for 1-hour. If radial artery patency is not maintained, a bolus of heparin 50 U/kg or a maximum of 5000 units is administered and the band is left in place for 2 hours.
Intervention Type
Other
Intervention Name(s)
Patent hemostasis and heparin
Intervention Description
Radial artery patency is verified. If not maintained, then a bolus of heparin 50 U/kg or a maximum of 5000 units is administered and the compression (TR band) is left in place for 2 hours.
Primary Outcome Measure Information:
Title
Radial artery occlusion
Description
Plethysmography, confirmed with duplex Doppler ultrasonography
Time Frame
At 30 days after the cathlab procedure
Secondary Outcome Measure Information:
Title
Radial artery occlusion
Description
Plethysmography, confirmed with duplex Doppler ultrasonography
Time Frame
At 24 hours after the cathlab procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all diagnostic cardiac cath patients Exclusion Criteria: warfarin therapy previous ipsilateral TRA lack of consent abnormal (type D) Barbeau test scleroderma thrombocytopenia or other contraindications to heparin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir B. Pancholy, MD
Organizational Affiliation
TCMC, Scranton (PA, USA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Commonwealth Medical College,
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18509
Country
United States
Facility Name
IUCPQ
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Sheth VS General Hospital,
City
Ahmedabad
Country
India

12. IPD Sharing Statement

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A-priori Versus Provisional Heparin on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis

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