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

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ClinicalTrials.gov Identifier: NCT01489917
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : May 8, 2012
Sponsor:
Collaborators:
Community Medical Center, Scranton, PA
Sheth Vadilal Sarabhai General Hospital
Information provided by (Responsible Party):
Olivier F. Bertrand, Laval University

Tracking Information
First Submitted Date  ICMJE December 1, 2011
First Posted Date  ICMJE December 12, 2011
Last Update Posted Date May 8, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2011)
Radial artery occlusion [ Time Frame: At 30 days after the cathlab procedure ]
Plethysmography, confirmed with duplex Doppler ultrasonography
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01489917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2011)
Radial artery occlusion [ Time Frame: At 24 hours after the cathlab procedure ]
Plethysmography, confirmed with duplex Doppler ultrasonography
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A-priori Versus Provisional Heparin on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis
Official Title  ICMJE Comparison of A-priori Versus Provisional Heparin Therapy on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Other: Patent hemostasis and heparin
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.
Study Arms  ICMJE
  • No Intervention: Compression without adjustment
    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.
  • Experimental: Patent hemostasis & heparin
    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: Other: Patent hemostasis and heparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2012)
428
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2011)
430
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01489917
Other Study ID Numbers  ICMJE PHARAOH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Olivier F. Bertrand, Laval University
Study Sponsor  ICMJE Olivier F. Bertrand
Collaborators  ICMJE
  • Community Medical Center, Scranton, PA
  • Sheth Vadilal Sarabhai General Hospital
Investigators  ICMJE
Principal Investigator: Samir B. Pancholy, MD TCMC, Scranton (PA, USA)
PRS Account Laval University
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP