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Dr. Aby Abraham, MD , DM Assistant Professor Dr. Alok Srivastava , MD, FRACP, FRCPA, FRCP

Dr. Aby Abraham, MD , DM Assistant Professor Dr. Alok Srivastava , MD, FRACP, FRCPA, FRCP Professor of Medicine & Dr . Sukesh C . Nair, MD, FRCPA ( Haematology ), Professor, Department of Haematology and Department of Transfusion Medicine & Immuno Haematology ,

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Dr. Aby Abraham, MD , DM Assistant Professor Dr. Alok Srivastava , MD, FRACP, FRCPA, FRCP

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  1. Dr. Aby Abraham, MD, DM Assistant Professor Dr. AlokSrivastava, MD, FRACP, FRCPA, FRCP Professor of Medicine & Dr. Sukesh C. Nair, MD, FRCPA (Haematology), Professor, Department of Haematology and Department of Transfusion Medicine & ImmunoHaematology, Christian Medical College, Vellore-632004.

  2. Why NICE Registry? • Off label uses >> Evidence-based indications • No consensus in dose and duration • Practice-based collection of data • NovoSeven®in Critical care Evaluation (NICE Registry) in April 2006 NovoSeven®Advisory Board –Dr. AlokSrivastava, MD, FRACP, FRCPA, FRCP Dr. M.B.Agarwal, MD, MNAMS, Dr. PalepuGopal, MD, FRCA, CCST, Dr. Rajesh Pande, MD, PDCC. Aim: To see would it be possible to gather new information? NICE Registry 2011

  3. Acknowledgements DR. A.C.SHUKLA MATA CHANAN DEVI HOSPITAL, DELHI. DR. A.SATISH ABHAYA HOSPITAL, BANGALORE. DR. AMITAVA SAHA B.P.PODDAR HOSPITAL, KOLKATA. DR. ANAND KATKAR BHARATI VIDHYAPEETH UNIVERSITY MEDICAL COLLEGE & HOSPITAL, PUNE. DR. ARIJIT BOSE AMRI, KOLKATA. DR. C.K.AURANGABADKER VIVEKANAND HOSPITAL, NAGPUR. DR. H. GADHIKAR DEENANATH MANGESHKAR HOSPITAL, PUNE. DR. KAYANOOD KADAGNATT JEHANGIR HOSPITAL & MEDICAL CENTRE, PUNE. DR. KULDEEP A.DALAL JASLOK HOSPITAL, MUMBAI. DR. MITUL P. CHARDA APOLLO HOSPITAL, CHENNAI. DR. M.BHATTACHARYA KOLKATA MEDICAL COLLEGE HOSPITAL, KOLKATA. DR. OMENDER SINGH MAX SUPER SPECIALITY HOSPITAL, SAKET. DR. PRABHAKAR. S APOLLO HOSPITAL, HYDERABAD. DR. PIYUSH RANJAN SIR GANGA RAM HOSPITAL, DELHI. DR. RANJIT DESHMUKH RUBY HALL CLINIC, PUNE. DR. RAJESH PANDE FORTIS HOSPITAL, NOIDA. DR. ROGESH BHURAT LOKMANYA HOSPITAL, PUNE. DR. ROHINI SRIDHAR APOLLO SPECIALITY HOSPITAL, MADURAI. DR. SAMEER PALTEWAR SURETECH HOSPITAL & RESEARCH INSTITUTE, NAGPUR DR. SHASHIKANT J. APTESAHYADRI SPECIALITY HOSPITAL, PUNE. DR. SHAILESH R. SINGI FERNANDEZ HOSPITAL, HYDERABAD. DR. SHIVINDER SINGH BASE HOSPITAL, DELHI. DR. VILAS E. TAMBE CRITICAL CARE UNIT, NAGPUR. DR. VIJAY RAMANAN RUBY HALL CLINIC, PUNE. DR. VINODAN MEDICAL TRUST HOSPITAL, COCHIN. DR. COL.SUDHIR MEHROTRA MH AMBALA MILITARY HOSPITAL DR. A.R. BASU COMMAND HOSPITAL, EASTERN COMMAND, KOLKATTA. DR. A.N. JHA MEDANTATHE MEDICITY HOSPITAL, GURGAON. DR. ADARSH CHAUDHRY MEDANTA THE MEDICITY HOSPITAL, GURGAON. DR. MRINAL SIRCAR FORTIS HOSPITAL, NOIDA. DR. P.AGARWAL MAX SUPER SPECIALITY HOSPITAL, SAKET. DR. SAMUEL SYLVESTER FRONTIER LIFELINE HOSPITAL, CHENNAI. Contd… NICE Registry 2011

  4. Acknowledgements DR. BALACHANDRAN NAIR. P KIMS, TRIVANDRUM. DR. NARENDRANATHAN. M KIMS, TRIVANDRUM. DR. RAJALAKEHMI. A KIMS, TRIVANDRUM. DR. SATISH. B KIMS, TRIVANDRUM. DR. AJITH K. NAIR KIMS, TRIVANDRUM. DR. VIJAYAN. K.N KIMS, TRIVANDRUM. DR. MATHEW THOMAS KIMS, TRIVANDRUM. DR. REVATHI RAJ APOLLO HOSPITAL, CHENNAI. DR. ZAHEER AHMED SAYEED APOLLO HOSPITAL, CHENNAI. DR. RAMNATH.S APOLLO HOSPITAL, CHENNAI. DR. VIJAYA SHANKAR APOLLO HOSPITAL, CHENNAI. DR. SOMNATH CHATERJEE MANIPAL HOSPITAL, BANGALORE. DR. VIJAYA MANOHAR AGADI HOSPITAL, BANGALORE. DR. KIRTHIVASAN FRONTIER LIFELINE HOSPITAL, CHENNAI. DR. BHARESH DEDHIA WOCKHARDT HOSPITAL, MUMBAI. DR. PRAVEEN MENON LOURDES HOSPITAL, ERNAKULAM. DR. MOHAN MATHEW LAKESHORE HOSPITAL & RESEARCH CENTRE, COCHIN. DR. KHALEEL MEDICAL TRUST HOSPITAL, COCHIN. DR. MADANMOHAN RAO HOPE HOSPITAL, HYDERABAD. DR. HARISH KRISHNA CHILDREN’S HOSPITAL, HYDERABAD. DR. VASUDEV MAX BALAJI HOSPITAL, DELHI. DR. ABHIJIT SARKAR PEERLESS HOSPITAL, KOLKATA. DR. S.K.SINGH AMRI HOSPITAL, KOLKATA. DR. MANASH GHOSH GNRC, GOUHATI. DR. NITIN.K / DR.ARUN AGARWAL BMC HOSPITAL & RESEARCH CENTRE, JAIPUR. DR. VISHAL SINGH FORTIS ESCORTS HOSPITAL, OKHLA. DR. NIRMALA AGARWAL SANT PARMANAND HOSPITAL, DELHI. DR. CHIRAG SHAH APOLLO HOSPITAL, AHMEDABAD. DR. CHIRAG MATRAVADIA STERLING HOSPITAL, RAJKOT. DR. SELVAKUMAR. MADRAS MEDICAL MISSION HOSPITAL, CHENNAI. Contd… NICE Registry 2011

  5. Acknowledgements DR. SHABBAR H.K JOAD FORTIS ESCORTS HOSPITAL, JAIPUR. DR. A.K. MANDAL FORTIS HOSPITAL, MOHALI. DR. BHARDWAJ / DR. BETTY ELIZABETH MADRAS MEDICAL MISSION HOSPITAL, CHENNAI. DR. SELVA KUMAR / DR. MANOHAR MADRAS MEDICAL MISSION HOSPITAL, CHENNAI. DR. VIMALA / DR. ROY/ DR. UDAYMADRAS MEDICAL MISSION HOSPITAL, CHENNAI. DR. NEVILLA AG SOLOMON APOLLO CHILDRENS HOSPITAL, CHENNAI. DR. THANGARAJ / DR. PAUL JUDE APOLLO SPECIALITY HOSPITAL, CHENNAI. DR. VIJAYSHANKAR APLLO SPECIALITY HOSPITAL, CHENNAI. DR. M. RAJA APOLLO SPECIALITY HOSPITAL, CHENNAI. DR. JAYASHREE GAJRAJ APOLLO SPECIALITY HOSPITAL, CHENNAI. DR. WAHIDA SURESH APOLLO SPECIALITY HOSPITAL, CHENNAI. DR. SRINIVAS APOLLO CHILDRENS HOSPITAL, CHENNAI. DR. LT. COL. P. MUKERJI ARMY HOSPITAL(R&R), DELHI. DR. COL TVSP MURTHY COMMAND HOSPITAL, LUCKNOW. DR. BRIG M LUTHRA ARMY HOSPITAL (R&R), DELHI. DR. RAJESH PANDE B.L KAPOOR MEMORIAL HOSPITAL, NEWDELHI. DR. DEEPA DAS PARAS HOSPITAL, GURGOAN. DR. VIVEK SINGH COLUMBIA ASIA HOSPITAL, GURAGOAN. DR. YATIN METHA MEDANTA INSTITUTE OF NEUROSCIENCES, GURAGAON. DR. RAJESH SHARMA ESCORTS HEART HOSPITAL, NEWDELHI. DR. VINEET SANKHLA APOLLO HOSPITALS, AHMEDABAD. DR. SIBABRATA BANNERJEE MISSION OF MERCY, KOLKATA. DR. SHOBHA / DR.SATISH KRISHNA SREE UTHRADOM THIRUNAL HOSPITAL,TRIVANDRUM. DR. MAMMEN CHANDY CHRISTIAN MEDICAL COLLEGE, VELLORE. DR. ALOK SRIVASTAVA CHRISTIAN MEDICAL COLLEGE, VELLORE. DR. AURO VISWABANDYA CHRISTIAN MEDICAL COLLEGE, VELLORE. DR. VIKRAM MATHEWS CHRISTIAN MEDICAL COLLEGE, VELLORE. DR. ARUNA KEKRE CHRISTIAN MEDICAL COLLEGE, VELLORE. DR. NAGAMANI SEN CHRISTIAN MEDICAL COLLEGE, VELLORE. DR. SUBRAMANIAN CHRISTIAN MEDICAL COLLEGE, VELLORE. DR. BIJU GEORGE CHRISTIAN MEDICAL COLLEGE, VELLORE. NICE Registry 2011

  6. Registry outline • Both web-based (www.niceindia.net) and non- web based • Components of Registry • Demographic data • Clinical History and Indication of NovoSeven® • Laboratory parameters • Dose of NovoSeven®and Response to this complication • Outcome NICE Registry 2011

  7. 19/04/2009 Christian Medical College, Vellore. 7 NICE Registry 2011

  8. 19/04/2009 Christian Medical College, Vellore. 8 NICE Registry 2011

  9. 19/04/2009 Christian Medical College, Vellore. 9 NICE Registry 2011

  10. Collection of data NICE Registry in April 2006 to Feb 2011

  11. Distribution of demographic data (n=380)

  12. Indications (n=380)

  13. Blood loss prior to the usage of NovoSeven® Milliliter * Number of patients

  14. Haematological parameters Hb – Haemoglobin, PT – Prothrombin time, aPTT – activated partial thromboplastin time

  15. Other parameters P = 0.132 P=0.004 Mean Mean N 84 54 54 N 69 38 38 p = 0.396 P = 0.373 p=0.054 p=0.212 Mean Mean N 42 17 23 8 23 8 N 37 10 17 8 17 8 NICE Registry 2011

  16. Abnormal LFT (n=46) p=0.494 p=0.569 p=0.455 Median N 25 19 29 20 24 17 SGOT - Serum glutamicoxaloacetictransaminase; SGPT - Serum glutamicpyruvictransaminase

  17. Dosage of NovoSeven®used (µg/kg)(Based on body weight) Median N 380 98 23 14 9

  18. Patients received 3 doses of NovoSeven®

  19. Patients received >3 doses of NovoSeven®

  20. NovoSeven®– Indication and doses Medical causes of bleeding

  21. NovoSeven®– Indication and doses Surgical causes of bleeding and trauma Median Dose (ug/kg)

  22. Blood products usage in different medical/surgical condition before and after the usage of NovoSeven®

  23. Blood products usage in liver disease R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  24. Blood products usage in UGI/LGI bleed R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  25. Blood products usage in thrombocytopenia R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  26. Blood products usage in dengue haemorrhagic fever R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  27. Blood products usage in anti-coagulopathies R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  28. Blood products usage in intracerebralhaemorrhage R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  29. Blood products usage in trauma R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  30. Blood products usage in other coagulopathies R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  31. Blood products usage in obstetric bleeding R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  32. Blood products usage in cardiac surgery R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  33. Blood products usage in other surgery R = RBCs, W = WBCs, P = Platelet, C = Cryoprecipitate, F = Fresh frozen plasma

  34. Blood products usage in different medical condition after the usage of rFVIIa • After the administration of rFVIIa, most of the patients received ≤ 3 units of RBCs • Transfusion of all blood products was substantially reduced

  35. Response Percentage N 98 67 48 24 159 76 96 45 40 59 43 12 35 23 16 8

  36. Overall efficacy of NovoSeven®

  37. Overall survival rate with usage of NovoSeven®

  38. Usage of NovoSeven® in different medical and surgical bleeding

  39. Usage of NovoSeven®in anticoag-associated bleeding n= 11; Median dose – 60 µg/kg Efficacy Survival rate

  40. Usage of NovoSeven®in intra-cerebral haemorrhage n= 70; Median dose –46.5 µg/kg Survival rate Efficacy

  41. Usage of NovoSeven® in cardiac surgery n= 66; Median dose –40 µg/kg Efficacy Survival rate

  42. Usage of NovoSeven® in trauma n= 44; Median dose –55 µg/kg Efficacy Survival rate

  43. Usage of NovoSeven® in obstetric bleeding n= 48; Median dose –60 µg/kg Efficacy Survival rate

  44. Usage of NovoSeven® in other surgery n= 31; Median dose –60 µg/kg Efficacy Survival rate

  45. Usage of NovoSeven® in UGI/LGI n= 40; Median dose –60 µg/kg Efficacy Survival rate

  46. Usage of NovoSeven® in liver disease n= 46; Median dose –60 µg/kg Efficacy Survival rate

  47. Usage of NovoSeven® in other coagulopathies n= 42; Median dose –60 µg/kg Efficacy Survival rate

  48. Usage of NovoSeven® in thrombocytopenia n= 39; Median dose –60 µg/kg Survival rate Efficacy

  49. Usage of NovoSeven® in dengue haemorrahagic fever n= 15; Median dose –75 µg/kg Efficacy Survival rate

  50. Adverse events

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