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Octaplas Publication Overview - August 2017

Pathogen Safety

Biesert L et al. OCTAPLAS: Eine virusinaktivierte Alternative zu gefrorenem Frischplasma  Infusionsther Transfusionsmed 1995;22(suppl 1):2-4

 

Biesert L and Suhartono H. Solvent/detergent treatment of human plasma--a very robust method for virus inactivation. Validated virus safety of OCTAPLAS Vox Sang 1998;74(suppl 1):207-212

 

Rollag H et al. Viral safety of blood derivatives by immune neutralization  Vox Sang 1998;74(1):2130217

 

Solheim BG et al. Viral safety of solvent/detergent-treated plasma Transfusion 2000;40(1):84-90

 

Svae TE et al. Prion safety of transfusion plasma and plasma-derivatives typically used for prophylactic treatment Transfus Apher Sci 2008;39(1):59-67

 

Neisser-Svae A et al. Prion removal effect of a specific affinity ligand introduced into the manufacturing process of the pharmaceutical quality solvent/detergent (S/D)-treated plasma OctaplasLG  Vox Sang 2009;97(3):226-233

 

Lawrie AS et al. The effect of prion reduction in solvent/detergent-treated plasma on haemostatic variables  Vox Sang 2010;99(3):232-238

 

Hellstern P and Solheim BG. The Use of Solvent/Detergent Treatment in Pathogen Reduction of Plasma Transfus Med Hemother 2011;38(1):65-70

 

Murphy WG.  Pathogen reduction: State of reflection in Ireland Transfusion Clinique et Biologique 2011;18(4):488-490

 

Heger A et al. Removal of prion infectivity by affinity ligand chromatography during OctaplasLG® manufacturing--results from animal bioassay studies  Vox Sang 2012;102(4):294-301

 

Neisser-Svae A and Seghatchian J. The state of the art of removal of prion proteins in SD-FFP, by specific prion affinity chromatography and its impact on the hemostatic characteristics of the product  Transfusion and Apheresis Science 2015;52(2):237-239

Kühnel D et al. Inactivation of Zika virus by solvent/detergent treatment of human plasma and other plama derived products and pasteurization of human serum albumin. Transfusion 2016, doi:10.1111/trf.13964

Stability Studies

Keller MK et al.  Thawed solvent/detergent-treated plasma: too precious to be wasted after 6 hours?  Blood Transfus 2012;10(3):360-367

 

 

 

Transfusion-Related Acute Lung Injury (TRALI) and HLA/HNA-antigens

Barz D.  Detection of antigen structures in blood cells in various prepared plasma transfusions  Anaesthesiologie und Reanimation 1994;19(6):155-158

 

Sinnott P et al. Presence of HLA antibodies in single-donor-derived fresh frozen plasma compared with pooled, solvent detergent-treated plasma (Octaplas).   Eur J Immunogenet 2004;31(6):271-274

 

Sachs U et al.  White blood cell-reactive antibodies are undetectable in solvent/detergent plasma Transfusion 2005;45(10):1628-1631

 

Solheim BG. Transfussion – related acute lung unjury (TRALI) – the preventable danger in intensive care?   ICM 2007;33(suppl):S1-2

 

Flesland O.  A comparison of complication rates based on published haemovigilance data   ICM 2007;33(suppl):S17-21

 

Blumberg N et al.  The mystery of transfusion-related acute lung injury  Transfusion 2011;51(10):2054-2057

Clinical experience in adults


Thrombotic Thrombocytopenic Purpura (TTP) and
Hemolytic Uremic Syndrome (HUS)

 

Harrison C et al.  Plasma exchange with solvent/detergent-treated plasma of resistant thrombotic thrombocytopenic purpura  Br J Haem 1996;94(4):756-758

 

Evans G et al. Solvent/detergent fresh frozen plasma as primary treatment of acute thrombotic thrombocytopenic purpura  Clin Lab Haematol 1999;21(2):119-123

 

Scully M et al. Cryosupernatant and solvent detergent fresh-frozen plasma (Octaplas) usage at a single centre in acute thrombotic thrombocytopenic purpura  Vox Sang 2007;93(2):154-158

 

Edel E et al. Efficacy and Safety Profile of Solvent/Detergent Plasma in the Treatment of Acute Thrombotic Thrombocytopenic Purpura: A Single-Center Experience   Transfus Med Hemother 2010;37(1):13-19

 

McDonald V et al. Rituximab pharmacokinetics during the management of acute idiopathic thrombotic thrombocytopenic purpura  J Thromb Haemos 2010;8(6):1201-1208


Lam K et al.  Successful management of recurrent pregnancy-related thrombotic thrombocytopaenia purpura in a renal transplant recipient  Nephrol Dial Transplant 2010;25: 2378–2380


Richter J et al. Successful management of a planned pregnancy in severe congenital thrombotic thrombocytopaenic purpura: the Upshaw-Schulman syndrome Transfus Med 2011;21(3): 211–213


Scully M et al. Thrombotic thrombocytopenic purpura and pregnancy: presentation, management, and subsequent pregnancy outcomes Blood 2014;124(2):211-219


McGuckin S et al. Characterization of the complications associated with plasma exchange for thrombotic thrombocytopaenic purpura and related thrombotic microangiopathic anaemias: a single institution experience  Vox Sang 2014;106(2):161-166


Scully M and Goodship T. How I treat thrombotic thrombocytopenic purpura and atypical haemolytic uraemic syndrome  Br J Haematol 2014;164(6):759-766


Scully M. Trends in the diagnosis and management of TTP: European perspective Transfus Apher Sci 2014;51(1):11-14


McGonigle AM et al.  Solvent/detergent treated plasma for the prevention of allergic reactions related to plasma transfusion  Transfusion 2015;55(3):157A


Sidhu D et al.  Two approaches to the clinical dilemma of treating TTP with therapeutic plasma exchange in patients with a history of anaphylactic reactions to plasma  J Clin Apher 2016, doi: 10.1002/jca.21475

Vendramin C et al.  A single-center prospective study on the safety of plasma exchange procedures using a double-viral-inactivated and prion-reduced solvent/detergent fresh-frozen plasma as the replacement fluid in the treatment of thrombotic microangiopathy Transfusion. 2016 Oct 23. doi: 10.1111/trf.13877

 


Cardiac surgery

 

Solheim BG et al.  The use of Octaplas in patients undergoing open heart surgery   Elsevier Science Publishers 1993, 253-262

 

Haubelt H et al.  Effects of solvent/detergent-treated plasma and fresh-frozen plasma on haemostasis and fibrinolysis in complex coagulopathy following open-heart surgery  Vox Sang 2002;82(1):9-14


Demeyere R et al. Comparison of fresh frozen plasma and prothrombin complex concentrate for the reversal of oral anticoagulants in patients undergoing cardiopulmonary bypass surgery: a randomized study  Vox Sang 2010;99(3):251-260

 


Transplantation

 

Freeman JW et al. A randomized trial of solvent/detergent and standard fresh frozen plasma in the treatment of the coagulopathy seen during Orthotopic Liver Transplantation  Vox Sang 1998;74(1):225-229

 

Rummler S et al. Extracorporeal Immune Modulation of sensitized recipients of thoracic organ transplantation   Transplant Med 2010;22:369-378

 

Koskinen AR et al. Complement activation during liver transplantation-special emphasis on patients with atypical hemolytic uremic syndrome  American Journal of Transplantation 2011; 11(9):1885–1895

 

Bindi ML et al. Solvent detergent vs. fresh frozen plasma in cirrhotic patients undergoing liver transplant surgery: a prospective randomized control study  Vox Sang 2013;105(2):137-143

 

Bartelmaos T et al. Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas  Vox Sang. 2013;105(2):137-143


Haugaa H et al. Low incidence of hyperfibrinolysis and thromboembolism in 195 primary liver transplantations transfused with solvent/detergent-treated plasma  Clin Med Res 2014;12(1-2):27-32

 

Liver disease

 

Williamson LM et al.  A randomized trial of solvent/detergent-treated and standard fresh-frozen plasma in the coagulopathy of liver disease and liver transplantation  Transfusion 1999;39:1227-34

 

Beck KH et al. Comparison of Solvent/Detergent-Inactivated Plasma and Fresh Frozen Plasma under Routine Clinical Conditions  Infus Ther Transfus Med 2000;27(3):144-148


Chekrizova V and Murphy WG. Solvent-detergent plasma: use in neonatal patients, in adult and paediatric patients with liver disease and in obstetric and gynaecological emergencies  Transfus Med 2006;16(2):85-91

 


Single Clottingfactor Deficiencies

 

Inbal A et al. Evaluation of solvent/detergent treated plasma in the management of patients with hereditary and acquired coagulation disorders Blood Coagulation and Fibrinolysis 1993;4(4):599-604

 

Hellstern P et al. Prospective study on efficacy and tolerability of solvent/detergent-treated plasma in intensive care unit patients  Infusionsther Transfusionsmed 1993;20(2):16-18


Beck KH et al.  Comparison of Solvent/Detergent-Inactivated Plasma and Fresh Frozen Plasma under Routine Clinical Conditions  Infus Ther Transfus Med 2000;27(3):144-148

 

O’Connell MPO er al. Solvent-detergent plasma as replacement therapy in a pregnant patient with factor V deficiency  J of Matern Fetal Neonatal Med 2004;16(1):69-70

 

Santagostino E et al.  Solvent/detergent plasma for prevention of bleeding in recessively inherited coagulation disorders: dosing, pharmacokinetics and clinical efficacy  Haematologica 2006; 91(5):634-639

 

Thomas JMC, et al. Therapeutic shoulder arthroscopy in patients with clotting disorders  Haemophilia 2008; 14(4): 859–861

 

Mehta P et al.  SLE with C1q deficiency treated with fresh frozen plasma: a 10-year experience  Rheumatology 2010;49(4):823-824


Hennaux V et al. Successful major surgical procedures in a severe FXI deficient patient using fresh frozen plasma: a case report  J Hematol Transfus 2016;4(1):1042-1046

 

 

Trauma

 

Hellstern P et al. Prospective study on efficacy and tolerability of solvent/detergent-treated plasma in intensive care unit patients  Infusionsther Transfusionsmed 1993;20(2):16-18


Beck KH et al. Comparison of Solvent/Detergent-Inactivated Plasma and Fresh Frozen Plasma under Routine Clinical Conditions   Infus Ther Transfus Med 2000;27(3):144-148

 

Nakstad AR, et al. Trends in transfusion of trauma victims - evaluation of changes in clinical practice   Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine 2011;19(23):2-9


Gaarder C, et al. The twin terrorist attacks in Norway on July 22, 2011: the trauma center response  J Trauma Acute Care Surg 2012;73:269-275

 

 

Gynaecology

 

Chekrizova V and Murphy WG.  Solvent-detergent plasma: use in neonatal patients, in adult and paediatric patients with liver disease and in obstetric and gynaecological emergencies Transfus Med 2006;16(2):85-91

 

Scully M et al.  Thrombotic thrombocytopenic purpura and pregnancy: presentation, management, and subsequent pregnancy outcomes  Blood 2014;124(2):211-219

Birkhoelzer S et al. Diagnostic dilemma: Severe thrombotic microangiopathy in pregnancy JICS 2017, DOI: 10.1177/1751143717715969

 

 

Burns

 

Koljonen V et al. The Use of Blood Products in Adult Patients with Burns   Scan J Surg 2016

 


Clinical experience in children

Salooja N et al. Severe factor V deficiency and neonatal intracranial haemorrhage: a case report   Haemophilia 2000;6(1):44-46

 

Chekrizova V and Murphy WG. Solvent-detergent plasma: use in neonatal patients, in adult and paediatric patients with liver disease and in obstetric and gynaecological emergencies  Transfus Med 2006;16(2):85-91

 

McDonald V et al. Acquired, noncongenital thrombotic thrombocytopenic purpura in children and adolescents: clinical management and the use of ADAMTS 13 assays   Blood Coagulation and Fibrinolysis 2010;21(3):245-250

 

Haller W et al. Successful isolated liver transplantation in a child with atypical hemolytic uremic syndrome and a mutation in complement factor H  Am J Transplant 2010;10(9): 2142–2147

 

Stanley R et al.  Use of Solvent Detergent Treated Ffp in Children with Severe Sepsis Transfusion Medicine 2010;20(1):18

 

Kim JJ et al. Plasma therapy for atypical haemolytic uraemic syndrome associated with heterozygous factor H mutations  Pediatr Nephrol 2011;26(11):2073-2076

 

Davin JC et al. Long-term renal function under plasma exchange in atypical hemolytic uremic syndrome  Pediatr Nephrol 2011;26:1915-1916

 

Luostarinen T et al. Thromboelastometry during intraoperative transfusion of fresh frozen plasma in pediatric neurosurgery  J Anesth 2012;26(5):770-774

 

Haas T et al. Perioperative course of FXIII in children undergoing major surgery   Pediatric Anesthesia 2012;22(7):641–646

 

Witt V et al.  Total plasma exchange using Octaplas; safety and coagulation parameters in children  J Clin Apheresis 2013;28:129

 

Hall SM et al. A paediatric tertiary referral center experience of OctaplasLG  BJH 2013;161(1):1-81,165A

Camazine MN, et al. Outcomes related to the use of frozen plasma or pooled solvent/detergent-treated plasma in critically iII children. Pediatr Crit Care Med 2017;18(5):e215-e223

 

 

 

 

S/D Plasma - Review

De Silvestro G et al. Virus-inactivated plasma - Plasmasafe: a one-year experience   Blood Transfus 2007;5(3):134-142

 

Svae TE et al. Solvent/Detergent Plasma   Production of plasma proteins for therapeutic use. Book 2012, Chapter 25,345-357

 

Liumbruno GM et al. Solvent/detergent-treated plasma: a tale of 30 years of experience  Expert Rev Hematol 2015;8(3):367-374

 

Marietta M et al. Is solvent/detergent plasma better than standard fresh-frozen plasma? A systematic review and an expert consensus document  Blood Transus 2016;14(4):277-286

 

 

Recently published Guidelines

Gaarder C et al.  Scandinavian Guidelines - "The massively bleeding patient"  Scandinavian Journal of Surgery 2008;97:15-36

 

Scully M et al. Guidelines on the diagnosis and management of thrombotic thrombocytopenic purpura and other thrombotic microangiopathies British Journal of Haematology 2012;158(3):323-335

 

Mumford AD, et al. Guideline for the diagnosis and management of the rare coagulation disorders British Journal of Haematology 2014;167(3):304-326

 

Scully M. Trends in the diagnosis and management of TTP: European perspective Transfusion and Apheresis Science 2014;51(1):11-14

 

Graham S and Markowitz MA. TRALI Risk Mitigation for Plasma and Whole Blood for Allogeneic Transfusion AABB 2014, January 29, Association Bulletin #14-02

 

NHF Board of Directors. MASAC recommendations concerning products licensed for the treatment of Hemophilia and other bleeding disorders Revised August 2015, MASAC document #237