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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01489917
Acronym
PHARAOH
Enrollment
428
Registered
2011-12-12
Start date
2009-05-31
Completion date
2011-12-31
Last updated
2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

radial artery occlusion, hemostasis, coronary intervention, radial approach

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.

Interventions

OTHERPatent 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.

Sponsors

Community Medical Center, Scranton, PA
CollaboratorOTHER
Sheth Vadilal Sarabhai General Hospital
CollaboratorOTHER
Olivier F. Bertrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Radial artery occlusionAt 30 days after the cathlab procedurePlethysmography, confirmed with duplex Doppler ultrasonography

Secondary

MeasureTime frameDescription
Radial artery occlusionAt 24 hours after the cathlab procedurePlethysmography, confirmed with duplex Doppler ultrasonography

Countries

Canada, India, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026