A-priori Versus Provisional Heparin on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis (PHARAOH)
|ClinicalTrials.gov Identifier: NCT01489917|
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : May 8, 2012
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Other: Patent hemostasis and heparin|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||428 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of A-priori Versus Provisional Heparin Therapy on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis|
|Study Start Date :||May 2009|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
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.
- Radial artery occlusion [ Time Frame: At 30 days after the cathlab procedure ]Plethysmography, confirmed with duplex Doppler ultrasonography
- Radial artery occlusion [ Time Frame: At 24 hours after the cathlab procedure ]Plethysmography, confirmed with duplex Doppler ultrasonography
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489917
|United States, Pennsylvania|
|Commonwealth Medical College,|
|Scranton, Pennsylvania, United States, 18509|
|Quebec City, Quebec, Canada|
|Sheth VS General Hospital,|
|Principal Investigator:||Samir B. Pancholy, MD||TCMC, Scranton (PA, USA)|