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

NCT ID: NCT01489917

Last Updated: 2012-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-12-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Patent hemostasis and heparin

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Community Medical Center, Scranton, PA

OTHER

Sponsor Role: collaborator

Sheth Vadilal Sarabhai General Hospital

OTHER

Sponsor Role: collaborator

Olivier F. Bertrand

OTHER

Sponsor Role: lead

Responsible Party

Olivier F. Bertrand

Project Leader Transradial Research and Education Fund

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Samir B. Pancholy, MD

Role: PRINCIPAL_INVESTIGATOR

TCMC, Scranton (PA, USA)

Locations

Commonwealth Medical College,

Scranton, Pennsylvania, United States

IUCPQ

Québec, Quebec, Canada

Sheth VS General Hospital,

Ahmedabad, , India

Countries

United States; Canada; India

Other Identifiers

PHARAOH

Identifier Type: -

Identifier Source: org_study_id