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
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Other: Patent hemostasis and heparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of A-priori Versus Provisional Heparin Therapy on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Radial artery occlusion [ Time Frame: At 30 days after the cathlab procedure ] [ Designated as safety issue: No ]
    Plethysmography, confirmed with duplex Doppler ultrasonography


Secondary Outcome Measures:
  • Radial artery occlusion [ Time Frame: At 24 hours after the cathlab procedure ] [ Designated as safety issue: No ]
    Plethysmography, confirmed with duplex Doppler ultrasonography


Enrollment: 428
Study Start Date: May 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489917

Locations
United States, Pennsylvania
Commonwealth Medical College,
Scranton, Pennsylvania, United States, 18509
Canada, Quebec
IUCPQ
Quebec City, Quebec, Canada
India
Sheth VS General Hospital,
Ahmedabad, India
Sponsors and Collaborators
Olivier F. Bertrand
Community Medical Center, Scranton, PA
Sheth Vadilal Sarabhai General Hospital
Investigators
Principal Investigator: Samir B. Pancholy, MD TCMC, Scranton (PA, USA)
  More Information

No publications provided

Responsible Party: Olivier F. Bertrand, Project Leader Transradial Research and Education Fund, Laval University
ClinicalTrials.gov Identifier: NCT01489917     History of Changes
Other Study ID Numbers: PHARAOH
Study First Received: December 1, 2011
Last Updated: May 7, 2012
Health Authority: United States: Institutional Review Board
Canada: Health Canada
India: Science and Engineering Research Council

Keywords provided by Laval University:
radial artery occlusion
hemostasis
coronary intervention
radial approach

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arterial Occlusive Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Vascular Diseases
Hemostatics
Calcium heparin
Heparin
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 31, 2014