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

Coronary Artery Disease Clinical Trial

— PHARAOH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489917
• Other study ID #: PHARAOH
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: May 7, 2012
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health CanadaIndia: Science and Engineering Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Canada	IUCPQ	Quebec City	Quebec
India	Sheth VS General Hospital,	Ahmedabad
United States	Commonwealth Medical College,	Scranton	Pennsylvania

Sponsors (3)

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

Countries where clinical trial is conducted

United States,  Canada,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion	Plethysmography, confirmed with duplex Doppler ultrasonography	At 30 days after the cathlab procedure	No
Secondary	Radial artery occlusion	Plethysmography, confirmed with duplex Doppler ultrasonography	At 24 hours after the cathlab procedure	No