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

This study has been completed.
Sponsor:
Collaborators:
Community Medical Center, Scranton, PA
Sheth Vadilal Sarabhai General Hospital
Information provided by (Responsible Party):
Olivier F. Bertrand, Laval University
ClinicalTrials.gov Identifier:
NCT01489917
First received: December 1, 2011
Last updated: May 7, 2012
Last verified: December 2011

December 1, 2011
May 7, 2012
May 2009
December 2011   (final data collection date for primary outcome measure)
Radial artery occlusion [ Time Frame: At 30 days after the cathlab procedure ] [ Designated as safety issue: No ]
Plethysmography, confirmed with duplex Doppler ultrasonography
Same as current
Complete list of historical versions of study NCT01489917 on ClinicalTrials.gov Archive Site
Radial artery occlusion [ Time Frame: At 24 hours after the cathlab procedure ] [ Designated as safety issue: No ]
Plethysmography, confirmed with duplex Doppler ultrasonography
Same as current
Not Provided
Not Provided
 
A-priori Versus Provisional Heparin on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis
Comparison of A-priori Versus Provisional Heparin Therapy on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Coronary Artery Disease
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
428
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   India
 
NCT01489917
PHARAOH
No
Olivier F. Bertrand, Laval University
Olivier F. Bertrand
  • Community Medical Center, Scranton, PA
  • Sheth Vadilal Sarabhai General Hospital
Principal Investigator: Samir B. Pancholy, MD TCMC, Scranton (PA, USA)
Laval University
December 2011

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