Administration of Neuraxial Anesthesia in Adults with Pre-Existing Bleeding Disorders and Tendencies: Methodology for Delphi Consensus Recommendations
Authors: Peterson Wynn , Martin Rachel , Carvalho Brendan , Carvalho Jose , Gadsden Jeff , Kouides Peter A. , Kuter David J. , Lavin Michelle , Rydz Natalia , Shore Eliane , Sholzberg Michelle 
Published: November 2020

Introduction
Epidural and spinal hematoma are rare but potentially devastating complications of neuraxial anesthesia. Individuals with pre-existing bleeding disorders and tendencies are likely at higher risk of these feared complications, however there are currently no comprehensive recommendations to direct the use of neuraxial anesthesia in these patients.
Objective
Our objectives were to create a set of consensus recommendations to advise clinicians on appropriate treatment thresholds prior to neuraxial anesthesia for patients with a variety of common and uncommon bleeding disorders and tendencies, and to propose safe hemostatic thresholds for administration and removal of neuraxial anesthetics in these individuals.
Materials and Methods
A steering committee comprised of 14 hematologists, anesthesiologists and methodologists created and refined a set of Delphi statements regarding the use of neuraxial anesthesia in the following pre-existing bleeding disorders and tendencies: von Willebrand disease, immune thrombocytopenia, gestational thrombocytopenia, platelet function disorders, thrombocytopenia associated with hypertensive disorders of pregnancy, coagulation factor deficiencies and fibrinogen disorders. Statements were developed using data obtained from a previously conducted scoping review of existing literature supplemented with the expert opinion of the steering committee in areas where there are minimal published data. Statements include varying hemostatic laboratory parameters in the context of high or low bleeding risk as measured by either a validated bleeding assessment tool (BAT) or pre-defined criteria for excessive bleeding.
We plan to recruit approximately 30 international panelists from the fields of hematology and anesthesiology to participate in a modified (i.e. electronic) Delphi technique. Three Delphi rounds will be conducted, during which we will ask panelists to rate their agreement with each Delphi statement on a 5-point Likert scale. Results will be analyzed for statistical consensus, defined as a Cronbach's alpha value of greater than or equal to 0.70. Statements that achieve consensus will be included in the final recommendations.
Results
Results of the modified Delphi study are pending.
Conclusions
Administration of neuraxial anesthesia in patients with pre-existing bleeding disorders and tendencies continues to present a significant management challenge for clinicians. We anticipate that the resultant recommendations will become a helpful tool for the future management of neuraxial anesthesia in these patients.

Disclosures
Martin: Borden Ladner Gervais LLP:Consultancy.Carvalho:Gauss Surgical:Consultancy.Kuter:Dova:Consultancy, Honoraria;Daiichi Sankyo:Consultancy, Honoraria;Actelion (Syntimmune):Consultancy, Honoraria, Other: Travel Expenses, Research Funding;Principia Biopharma:Consultancy, Honoraria, Other, Research Funding;Protalix Biotherapeutics:Consultancy;Shionogi:Consultancy;Protalex:Consultancy, Honoraria, Research Funding;Kezar Life Sciences, Inc:Other, Research Funding;CRICO:Consultancy, Honoraria;Genzyme:Consultancy, Honoraria;Principia:Consultancy, Research Funding;Shire:Consultancy, Honoraria;Shionogi:Consultancy, Honoraria;Sanofi (Genzyme):Consultancy, Honoraria;Incyte:Consultancy, Honoraria;Immunovant:Consultancy, Honoraria;Kyowa-Kirin:Consultancy, Honoraria;Merck Sharp Dohme:Consultancy, Honoraria;Momenta:Consultancy, Honoraria;Novartis:Consultancy, Honoraria;Pfizer:Consultancy, Honoraria;Zafgen:Consultancy, Honoraria;Up-To-Date:Consultancy, Honoraria, Patents & Royalties;UCB:Consultancy, Honoraria;Platelet Disorder Support Association:Consultancy, Honoraria;Argenx:Consultancy, Honoraria, Other: Travel Expenses, Research Funding;Bristol-Myers Squibb:Consultancy, Honoraria, Other: Travel Expenses, Research Funding;Caremark:Consultancy, Honoraria;Immunovant:Other: Travel Expenses, Research Funding;Alnylam:Consultancy, Honoraria, Other: Travel Expenses, Research Funding;Agios:Consultancy, Honoraria, Other: Travel Expenses, Research Funding;Amgen:Consultancy, Honoraria, Other: Travel Expenses, Research Funding;Takeda (Bioverativ):Consultancy, Honoraria, Other, Research Funding;Rigel:Consultancy, Honoraria, Other, Research Funding;Protalex:Consultancy, Honoraria, Other, Research Funding.Lavin:Tremeau Pharmaceuticals:Membership on an entity's Board of Directors or advisory committees;Siemens Healthineers:Other: Speaker's fees;Takeda:Research Funding;Shire:Research Funding.Sholzberg:Takeda:Honoraria, Other: Scientific Advisory Board, Research Funding;Novartis:Honoraria, Other: Scientific Advisory Board;NovoNordisk:Honoraria, Other: Scientific Advisory Board;Octapharma:Honoraria, Other: Scientific Advisory Board, Research Funding;Amgen:Honoraria, Other: Scientific Advisory Board, Research Funding.