Caraco v. Novo Nordisk (Prandin®):Code CaseOn April 17, 2012, the U.S. Supreme Court issued a unanimous decision delivered by Justice Kagan in Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S , reversing the Federal Circuit and holding that a generic manufacturer (Caraco) may force correction of an Orange Book use code that inaccurately describes a brand company’s (Novo’s) p
Harvesttech.comPerfusion 2007; 22: 41–50
Quality assessment of platelet rich plasma
during anti-platelet therapy*
Chad W Smith1, Robert S Binford2, David W Holt3 and David P Webb4 1Tennessee Perfusion Services, PLLC, Centennial Medical Center, Cardiothoracic Surgery, Nashville, Tennessee, USA.
Graduate Degree Completion Program, School of Allied Health Professions, University of Nebraska Medical Center,Omaha, Nebraska, USA;2Centennial Medical Center, Cardiothoracic Surgery, Nashville, Tennessee, USA;3Program Director Graduate Degree Completion, School of Allied Health Professions, University of Nebraska MedicalCenter, Omaha, Nebraska, USA;4Director of Perfusion Services, Vanderbilt Medical Center, Nashville, Tennessee, USA Platelet rich plasma (PRP) is being used with increased fre-
evidence of decreased growth factors delivered to the
quency in many surgical procedures for its known benefits
surgical wound site in the presence of acetylsalicylic acid
of accelerated surgical wound site healing. Speculations
(ASA) and/or Plavix (clopidogrel bisulfate). Evidence
in its efficacy in the presence of anti-platelet therapy have
in this pilot study supports the use of PRP for patients
been proposed. To aid in defining a quality platelet rich
receiving Plavix and aspirin therapy without compro-
plasma product in the presence of acetylsalicylic acid
mising the quantity of specific growth factors delivered to
(ASA) and Plavix (clopidogrel bisulfate), we investigated
a wound site. Perfusion (2007) 22, 41–50.
three (3) groups (nϭ18) of cardiac surgical patients
receiving PRP. Platelet function test, platelet concentra-
tion, and quantification of growth factors (PDGF-bb and
Key Words: Platelet Rich Plasma, Plavix, Aspirin, PDGF-
TGF-b1) were evaluated. Results showed no statistical
therapeutics delivered by clinicians. It is hoped thatthis paper may aid in this effort.
Surgical wound healing is a vital element in the suc- Establishment of a quality PRP product has been cess of any surgical intervention. This not only pro- speculated to include platelet function measure- motes surgical success, but aids in keeping surgical ments as well as a patient interview to gain knowl- costs minimal. It has been well documented that the edge of their medical habits and/or blood disor- addition of platelets to a wound site alone provides ders.13 Much of the literature suggests viability and a source of growth factor release essential for tis- quantity of platelets, manner of sequestration, and sue and bone healing.1–8 This procedure involves application of PRP aid in the release of growth fac- using small amounts of autologous whole blood, cen- tors to enhance the quality of this therapeutic inter- trifuging to obtain enriched platelets and plasma, and vention.1,14 The use of viable platelets is mandatory mixing with calcified thrombin during the applica- and preparation of PRP should make every attempt tion to the surgical wound site, thus, increasing to ensure this quality of the product. Platelet func- wound healing processes and promoting decreased tion testing prior to the use of this therapeutic has wound infections over current standard practices.9–11 been suggested. Additionally, using venous blood Doukas J et al. express complete healing without anti-coagulated with anticoagulant citrate dextrose, excessive scar formation while investigating growth formula A (ACD-A) is the accepted gold standard to factors (PDGF-bb).12 As with new technologies, date.8 This will allow the maximum potential growth much of the efficacy attributed to this therapy has factors to be delivered to the wound site.14 The been with clinical observation. Much investigation duration of the venous blood draw and the volume and clinical research should be invoked with new of whole blood have shown to affect the quality of therapeutics to establish standardizations for quality platelets obtained for producing PRP.13 Waters, J etal. reported that an effort should be made to draw *Presented at the University of Nebraska Medical Center from the venous system to gain optimal platelets Research Symposium, Omaha, Nebraska, USA, 18 January, 2006 during the whole blood draw.13 In conjunction, Address for correspondence: Chad W Smith, Tennessee Perfusion ACD-A will achieve optimum platelet preservation Services, PLLC, 5549 Saddlewood Lane, Brentwood, Tennessee and anticoagulation. When citrate phosphate dex- 37027, USA.
E-mail: Chadsmail@comcast.net trose (CPD) is used, a 10% less effectiveness in 2007 SAGE Publications. All rights reserved. Not for commercial use or unauthorized distribution.
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