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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 7, 2014
Last verified: February 2014
  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 or knee arthroplasty and treated by antiplatelet mono/bi-therapy


Condition
Acute or Programmed Hip Replacement (Gamma Nail, Total Prosthesis or Throuhg DHS) / Knee Surgery

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/Single 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 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.


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 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)


Estimated Enrollment: 200
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)
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 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.

  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 antiplatelelt mono/bitherapy 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 profile with respect to the CYP 2C19*2 carriage. The analysis will bestratified according to ethnicity to avoid biases.

Criteria

Inclusion Criteria:

  • ≥18 years
  • Patient in antiplatelet monotherapy (aspirin or clopidogrel) or dual therapy (aspirin + clopidogrel / prasugrel / ticagrelor) in the context of secondary prevention after:

    • acute coronary syndrome
    • and / or intracoronary stenting
  • Planned or urgent hip (gamma nail, total prosthesis or through DHS) or knee arthroplasty
  • Informed consent of the participant
  • Patient receiving a social security scheme or entitled

Exclusion Criteria:

  • Polytrauma
  • Anemia <9g/dL
  • Indication for oral anticoagulation
  • Pelvic fracture justifying complex surgery
  • Ongoing or recent major bleeding or recent major surgery (< 3 weeks)
  • Liver failure
  • Thrombopenia <80 000/µl
  • Lack of health insurance
  • Mental disability
  • Participation to any other research protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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    minville.v@chu-toulouse.fr   
Principal Investigator: Vincent MINVILLE, MD         
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: February 7, 2014
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 19, 2014