Assessment of Blood Loss With a Point Of Care Device (BLOOD)
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
Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee Surgery
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of Blood Loss With a Point Of Care Device During Hip/Knee Surgery Performed On Dual/Single Antiplatelet Therapy|
- Perioperative blood loss in mL assessed by NADLER & Mercurial formula* and PRU**/ARU*** as measured using the VerifyNow®P2Y12 and aspirin assays at baseline [ Time Frame: day 1- day 5 ] [ Designated as safety issue: No ]Perioperative (day 1-day 5) blood loss in mL assessed by NADLER & Mercuriali formula* and PRU**/ARU*** as measured using the VerifyNow®P2Y12 and aspirin assays at baseline.
- Evaluate the correlation between clopidogrel genetic metabolizer status**** and perioperative blood loss. [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]When the patient discharges of surgery department
- To evaluate clopidogrel and aspirin pharmacodynamic response at discharge according to metabolizer status. [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]When the patient discharges of surgery department
Biospecimen Retention: Samples With DNA
salivary kit (Oragnèe-DNA approved by FDA) or blood (2 tubes 2.5ml)
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Planned hip or knee arthroplasty
Patients with planned hip or knee arthroplasty
urgent hip or knee arthroplasty
Patients with hip or knee arthroplasty in emergency.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430273
|Contact: Jean-Philippe COLLET, MD,PhD||00331 42 16 30 firstname.lastname@example.org|
|Institute of cardiology - Pitié Salpêtrière Hospital||Recruiting|
|Paris, France, 75013|
|CHU Toulouse - Hôpital de Rangueil - Anésthésie-Réanimation||Recruiting|
|Toulouse, France, 31403|
|Contact: Vincent MINVILLE, MD 33 1 05 61 32 35 21 email@example.com|
|Principal Investigator: Vincent MINVILLE, MD|
|Principal Investigator:||COLLET Jean-Philippe, MD-PhD||Assistance Publique - Hôpitaux de Paris|