Assessment of Blood Loss With a Point Of Care Device (BLOOD)

This study is not yet open for participant recruitment.
Verified September 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01430273
First received: August 4, 2011
Last updated: October 2, 2012
Last verified: September 2012
  Purpose

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 replacement and treated by dual antiplatelet therapy (APT) (clopidogrel+aspirin).


Condition
Acute Arthropathy of Knee, Patella, Tibia, or Fibula

Study Type: Observational
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 Antiplatelet Therapy

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Perioperative blood loss in mL assessed by NADLER & Mercurial formula* and PRU**/ARU*** as measured using the VerifyNow®P2Y12 et 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 et aspirin assays at baseline.


Secondary Outcome Measures:
  • 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 chirurgie 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 chirurgie department


Biospecimen Retention:   Samples With DNA

salivary kit (Oragnèe-DNA approved by FDA) or blood (2 tubes 2.5ml)


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

Type of study : Prospective Non interventional Multicenter registryPrincipal Investigator: Collet Jean-PhilippeRational : 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 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 an 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**/ARU*** as measured using the VerifyNow®P2Y12 et aspirin assays at baseline. Secondary objectives: (i) to evaluate the correlation between clopidogrel genetic metabolizer status**** and perioperative blood loss. To evaluate clopidogrel and aspirin 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 Phenotype is defined according to the carriage of the loss/gain-of function allelle 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 patientsStudy duration: Two years. Study duration per subject: length of hospital stay with a maximum duration of 30 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study targets CAD patients exposed to dual antiplatelelt therapy who need planned or emergency knee/hip athroplasty. This innovative study will bring new insights on how works antiplatelet therapy during the perioperative period according to drug exposition and metabolizer profile.

Patients ethnicity will be recorded and defined according to the place of birth of the participants and of their parents given the identification of the metabolizer profil with respect to the CYP 2C19*2 carrriage. The analysis will bestratified according to ethnicity to avoid biases.

Criteria

Inclusion Criteria:

-≥18 years

  • Chronic exposure to aspirin and clopidogrel following acute coronary syndrome or coronary stent placement
  • Planned or urgent hip or knee arthroplasty
  • Informed consent of the participant

Exclusion Criteria:

  • Polytrauma
  • Anemia <9g/dL
  • Indication for oral anticoagulation
  • Patient on single antiplatelet therapy
  • Ongoing or recent major bleeding or recent major surgery
  • Liver failure
  • Thrombopenia <80 000/µl
  • Lack of health insurance
  • Mental disability
  • Participation to any other research protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430273

Contacts
Contact: Jean-Philippe COLLET, MD,PhD 00331 42 16 30 13 jean-philippe.collet@psl.aphp.fr

Locations
France
Institute of cardiology - Pitié Salpêtrière Hospital Not yet recruiting
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: COLLET Jean-Philippe, MD-PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01430273     History of Changes
Other Study ID Numbers: NI10028, 2010-A01454-35
Study First Received: August 4, 2011
Last Updated: October 2, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Antiplatelet therapy
Surgery
Bleeding
Platelet aggregation

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013