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Completed

NCT Number: NCT01489917

A-priori Versus Provisional Heparin 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ, Québec, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patent hemostasis and heparin

Other

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 outcomes

  1. Radial artery occlusion

    Time frame: At 30 days after the cathlab procedure

    Plethysmography, confirmed with duplex Doppler ultrasonography

Secondary outcomes

  1. Radial artery occlusion

    Time frame: At 24 hours after the cathlab procedure

    Plethysmography, confirmed with duplex Doppler ultrasonography

Sponsors and collaborators

Lead sponsor

Olivier F. Bertrand

Other

Collaborators

  • Community Medical Center, Scranton, PA
  • Sheth Vadilal Sarabhai General Hospital

Registry information

Official study title

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

Acronym: PHARAOH

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 12, 2011
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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