Double blind single center clinical trial to compare the incidence of radial artery occlusion (RAO) using standard doses of Unfractionated Heparin (UFH) vs. high doses of UFH.
Radial artery occlusion (RAO) is one of the most common complications in transradial artery interventions (up to 30% of cases if specific measures are not taken to prevent it) and is related to the prothrombotic state of the patient, the scarce distal flow to the access site and the trauma caused to the artery during the procedure. Currently worldwide, the transradial (TRA) access is the most widely used access for coronary angiography (in up to 90% of the procedures) because the transradial approach is associated with lower rates of vascular complications and event mortality (compared to the femoral access). Although TRA access is safer, it is not free of complications, being one of the most important the RAO. There are universal efforts to reduce RAO improving every aspects of the technique, from the type of introducer to the hemostasis time to a distal TRA, with evidence suggesting that higher doses of UFH can also decrease RAO to a greater extent. The decrease in the incidence of RAO have been proposed to be up to 2.8 times with high doses of UFH (single-center, retrospective study that compared regular not standard doses of UFH versus higher doses of UFH) although no proper prospective clinical trial have been undertaken to prove this. The standard dose that has shown a lower rate of RAO is 5000 IU, which will be compared with 100 IU / Kg of UFH, with a randomized, prospective, double-blind design, with short-term (24-hour) follow-up with Doppler ultrasound (DUS) and its correlation with plethysmography to document RAO, and in occluded arteries, there will be a 30-day follow-up to determine the recanalization (or persistent occlusion) rates by DUS (and plethysmography). In order to address safety concerns of higher UFH doses, all the potential hemorrhagic complications will be evaluated during the study follow-up time and higher hemorrhagic risk patients are going to be excluded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,988
Before removing the introducer sheath, the 2nd operator will pass the missing UFH dose to the first operator to reach 100 IU per kg of body weight in a 10 ml syringe mixed with 0.9% saline solution. The blinded first operator will administer this without knowing if it is saline or the supplemental dose of unfractionated heparin.
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Tlalpan, Mexico
RECRUITINGRadial artery occlusion (RAO).
The incidence of RAO (with DUS and plethysmography).
Time frame: 24 hours.
Radial artery occlusion (RAO).
The incidence of RAO (with DUS and plethysmography).
Time frame: 30 days.
Time to hemostasis.
Time to hemostasis, from the removal of the introducer sheath to hemostasis.
Time frame: 24 hours.
Diameters of the radial artery.
Minimum, maximum and mean diameters of the radial artery by vascular ultrasound.
Time frame: 24 hours.
Correlation of RAO by oximetric plethysmography and DUS.
Correlation of plethysmography and DUS for the determination of RAO.
Time frame: 30 days.
Hemorrhagic Complications.
Compare the incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: The BARC-2 scale: * Type 0 * Type 1 * Type 2 * Type 3 * Type 4 * Type 5
Time frame: 30 days.
Hemorrhagic Complications.
Compare the incidence of bleeding complications according to the Early Discharge After Transradial Stenting of Coronary Arteries Study (EASY) scale: The EASY scale: * Grade I * Grade II * Grade III * Grade IV * Grade V
Time frame: 24 hours.
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