PREDICT: PREdic-ng bleeding In cri-cally ill Children with Thrombocytopenia. Marianne Nellis, MD, MS 3/11/15 BloodNet

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1 PREDICT: PREdic-ng bleeding In cri-cally ill Children with Thrombocytopenia Marianne Nellis, MD, MS 3/11/15 BloodNet

2 Conflicts of Interest Disclosure I have no financial rela-onships to report regarding this presenta-on. I will be discussing the use of a trademarked device.

3 Background Treatments - Fluid resuscita-on - Repeated transfusions - An-coagula-on Thrombocytopenia - Chemotherapy - Stem Cell Transplanta-on Cri-cal Illness - Ac-va-on of -ssue factor - Acidosis - Hypothermia - Inflamma-on - Sepsis, DIC - Organ Dysfunc-on (renal, liver) Risk of Bleeding Invasive Procedures

4 Evidence for Prophylac-c Platelet Transfusion Consensus Recommenda-ons: AABB: maintain platelet count of 10 x 10 9 cells/l to reduce risk of spontaneously bleeding 1 Cochrane review: no evidence that prophylac-c plt transfusion policy prevents bleeding 2 General prac-ce: Plts are inappropriately transfused ~50% of -me in non- bleeding pa-ents with plt count > 80 x 10 9 cells/l 3 Prac-ce of prophylac-c platelet transfusions known to vary 4 Local prac-ce: Review of 707 platelet transfusions over past 3 years, average platelet count in thrombocytopenic pa-ents at -me of transfusion was 34 x 10 9 cells/l (SD 21 x 10 9 cells/l) 1 Kaufman RM et al. Platelet Transfusion: A Clinical Prac-ce Guideline from the AABB. Annals of Internal Medicine 2015; 162(3): Estcourt L et al. Prophylac-c platelet transfusion for preven-on of bleeding in pa-ents with haematological disorders ader chemotherapy and stem cell transplanta-on. Cochrane Database Syst Rev 2012 May 16; 5:CD Leal- Noval SR et al. Impact of na-onal transfusion indicators on appropriate blood usage in cri-cally ill pa-ents. Transfusion 2011; 51: Estcourt LJ, Birchall J, Lowe D, et al. Platelet transfusions in haematology pa-ents: Are we using them appropriately? Vox Sang 2012; 103:

5 Morbidity Associated with Transfusion Therapy

6 Is there a beger predictor of bleeding other than platelet count that can guide our prophylac-c platelet transfusion?

7 Rota-onal Thromboelastometry (ROTEM) Whole blood assay that assesses shear elas-city of clot Use in adults: Evalua-on of coagulopathy in sepsis 1 Guide transfusion protocols in complex cardiac surgery and liver transplanta-on 2,3 Use in children: During or ader cardiopulmonary bypass 4 During craniosynostosis repair 5 Availability: Accessible within ins-tu-on to ¼ of PICU providers 6 Rarely used

8 Absolute Immature Platelet Immature platelet popula-on newly synthesized in the bone marrow à early marker of thrombopoe-c regenera-on Strongly associated with bleeding in adults with hematological malignancy 1 Number (AIPN) 1 Estcourt LJ. Prospec-ve observa-onal cohort study of the associa-on of thromboelastometry, coagula-on and platelet parameters and bleeding in pa-ents with haematological malignancies- the ATHENA study. Bri?sh Journal of Hematology 2014; 166:

9 Hypothesis Alterna-ve measures of coagula-on (i.e. ROTEM profile or platelet re-c) will be more predic-ve of bleeding than absolute platelet count in cri-cally ill children with chemotherapy or SCT induced thrombocytopenia

10 Objec-ves Primary: To describe the ROTEM profile in cri-cally ill children with chemotherapy or SCT induced thrombocytopenia before and ader prophylac-c platelet transfusion Secondary: To evaluate whether the parameters measured by ROTEM show a stronger associa-on with bleeding than the platelet count in cri-cally ill children with chemotherapy or SCT induced thrombocytopenia To evaluate whether the AIPN shows a stronger associa-on with bleeding than platelet count in this popula-on

11 Research Design Inclusion Criteria Age 4 weeks 18 years Expected length of stay in PICU > 24hrs Thrombocytopenia (plt count < 100 x 10 9 cells/l) Bone marrow suppression Receipt of chemo in last month Status post transplant in last year Exclusion Criteria Inherited disorder of hemostasis Immune thrombocytopenia Veno- occlusive disease Receiving aspirin Neonates < 1 month of age or < 4kg

12 Research Design Daily: ROTEM profile and CBC (with AIPN) WHO Bleeding Grade Decision to prescribe prophylac-c platelet transfusion led to provider At -me of prophylac-c platelet transfusion: Assure above blood assays within four hours of transfusion (if not repeat before transfusion) Repeat ROTEM profile and CBC (with AIPN) four hours ader transfusion Addi-onal data collec-on: pa-ent age, gender, ethnicity, admiqng diagnosis, receipt of an-- coagula-on or an-- platelet agents, PELOD score, transfusion data

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14 Sta-s-cal Analysis Pilot study of 50 pa-ents at MSKCC and NYPH- WCMC over 18 month period 95% confidence intervals can be constructed within +/- 12% of true incidence of bleeding To assess associa-on btwn lab parameters and bleeding events: Generalized es-ma-ng equa-ons (GEE) with clustering at pa-ent level To compare laboratory parameters: Odds ra-os (p- vales calculated by McNemar s test) ROC curves (compared with DeLong test)

15 ACKNOWLEDGEMENTS Dr. Sujit Sheth Dr. Melissa Cushing Dr. Farid Boulad Dr. Phil Spinella QUESTIONS? CONCERNS? Please feel free to contact me at