Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee Surgery Clinical Trial
Official title:
Assessment of Blood Loss With a Point Of Care Device During Hip/Knee Surgery Performed On Dual/Single Antiplatelet Therapy
Main Objective: The purpose of this study is to demonstrate whether there is a correlation between perioperative blood loss and the degree of platelet inhibition assessed by a point of care assay in patients undergoing hip or knee arthroplasty and treated by antiplatelet mono/bi-therapy
Type of study : Prospective, non-interventional, multicenter registry Principal Investigator:
Collet Jean-Philippe Rational: Discontinuation of antiplatelet therapy in patients with
established coronary artery disease (CAD) has become an increasingly important concern given
the risk of recurrent arterial event. Exaggerated concern about increased procedure-related
bleeding remains the major factor for premature discontinuation of APT. Interruption
modalities and their impact on perioperative bleeding has never been prospectively evaluated
and it is accepted that the maximum duration of interruption should not exceed 5 days for
Clopidogrel/Ticagrelor and 7 days for Prasugrel given the fact that the remaining
antiplatelet effect of APT is observed in less than 50% of patients after 3 days of
interruption. Resuming APT after the operation has never been studied and remains a complex
situation during anticoagulation is often prescribed to prevent deep vein thrombosis further
increasing perioperative bleeding.
Hypotheses: (i) the volume of perioperative blood loss is correlated to the degree of
platelet inhibition. (ii) Clopidogrel metabolizer status as defined by genetic profile is
also correlated to perioperative blood loss. (iii) Resuming antiplatelet therapy during the
perioperative period is not associated with a significant recovery of the antiplatelet
effect.
Primary endpoint: Perioperative (day 1-day 5) blood loss in mL assessed by NADLER & Mercurial
formula* and PRU** (for patients under Clopidogrel/ARU*** as measured using the
VerifyNow®P2Y12 and aspirin assays at baseline. Secondary objectives: (i) to evaluate the
correlation between clopidogrel genetic metabolizer status**** and perioperative blood loss.
To evaluate antiplatelet pharmacodynamic response at discharge according to metabolizer
status. Definition*Blood loss in mL of Red Blood Cell (RBC) = Compensated RBC Volume (1
Pack=150mL) + Non Compensated RBC Vol. (Total Blood Loss : Ht D-1-Ht D+5). *PRU=Platelet
Reaction Unit. It is a specific measure of on-clopidogrel platelet reactivity. Cut-off value
is for defining high-on clopidogrel platelet reactivity is 230. **ARU=Aspirin Reaction Unit.
It is a specific measure of on-aspirin platelet reactivity. Cutoff value to identify high
on-aspirin platelet reactivity is 550. ***Clopidogrel Metabolizer Phenotype is defined
according to the carriage of the loss/gain-of function allele 2C19*2-*8/*17 as follows: SM
for slow metabolizer: (*2-*8/*2-*8) ; Ultrafast Metabolizer (FM): (*17/*17) ;
Normal/intermediate (M): (wt/wt, wt/*17, *2-*8/*17 or *2-*8/wt)
Number of subjects : 200 patients
Study duration: Two years.
Study duration per subject: length of hospital stay with a maximum duration of 30 days.
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