Erythropoietin in traumatic brain injury (EPO-TBI): A double-blind randomised controlled trial

The Lancet

Volumn 386, Issue 10012, 2015, Pages 2499-2506

  Nichol, Alistair ^a,c,d,e   French, Craig ^b,f   Little, Lorraine ^a   Haddad, Samir ^g   Presneill, Jeffrey ^a,h,i   Arabi, Yaseen ^a,j   Bailey, Michael ^a   Cooper, D James ^a,c   Duranteau, Jacques ^k   Huet, Olivier ^a,l   Mak, Anne ^a,c   McArthur, Colin ^a,n   Pettilä, Ville ^a,m   Skrifvars, Markus ^m   Vallance, Shirley ^a,c   Varma, Dinesh ^c   Wills, Judy ^a,c   Bellomo, Rinaldo ^a,b,o  

^a MONASH UNIVERSITY   (Australia)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c The Alfred   (Australia)

^d UNIVERSITY COLLEGE DUBLIN   (Ireland)

^e ST VINCENT S UNIVERSITY HOSPITAL   (Ireland)

^f WESTERN HEALTH   (Australia)

^g KING SAUD BIN ABDULAZIZ UNIVERSITY FOR HEALTH SCIENCES   (Saudi Arabia)

^h UNIVERSITY OF QUEENSLAND   (Australia)

ⁱ ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

^j KING SAUD BIN ABDULAZIZ UNIVERSITY FOR HEALTH SCIENCES   (Saudi Arabia)

^k BICÊTRE HOSPITAL   (France)

^l SERVICE DE RHUMATOLOGIE   (France)

^m UNIVERSITY OF HELSINKI   (Finland)

ⁿ AUCKLAND CITY HOSPITAL   (New Zealand)

^o AUSTIN HOSPITAL   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ERYTHROPOIETIN;

ADULT; ALLERGIC REACTION; ARTICLE; BLEEDING; CARDIOVASCULAR DISEASE; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DEEP VEIN THROMBOSIS; DISABILITY SEVERITY; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; GASTROINTESTINAL DISEASE; GLASGOW OUTCOME SCALE; HEART ARREST; HEART INFARCTION; HUMAN; HYPERVENTILATION; HYPOTENSION; INJURY SEVERITY; INTENTION TO TREAT ANALYSIS; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PARALLEL DESIGN; PERSISTENT VEGETATIVE STATE; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SEIZURE; SENSITIVITY ANALYSIS; SEPSIS; SURVIVAL; TRAUMATIC BRAIN INJURY; AUSTRALIA; BRAIN INJURIES; CLINICAL TRIAL; EUROPE; INCIDENCE; MIDDLE AGED; NEW ZEALAND; SAUDI ARABIA; TREATMENT OUTCOME; VENOUS THROMBOSIS; YOUNG ADULT;

ADULT; AUSTRALIA; BRAIN INJURIES; DOUBLE-BLIND METHOD; ERYTHROPOIETIN; EUROPE; FEMALE; GLASGOW OUTCOME SCALE; HUMANS; INCIDENCE; MALE; MIDDLE AGED; NEW ZEALAND; SAUDI ARABIA; TREATMENT OUTCOME; VENOUS THROMBOSIS; YOUNG ADULT;

EID: 84955597458     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(15)00386-4     Document Type: Article

References (30)

1. JA Myburgh, DJ Cooper, SR Finfer et al. Epidemiology and 12-month outcomes from traumatic brain injury in Australia and New Zealand J Trauma 64 2008 854 862
2. AIR Maas, B Roozenbeek, GT Manley Clinical trials in traumatic brain injury: past experience and current developments Neurotherapeutics 7 2010 115 126
3. J Myburgh, DJ Cooper, S Finfer et al. Saline or albumin for fluid resuscitation in patients with traumatic brain injury N Engl J Med 357 2007 874 884
4. SA Bernard, V Nguyen, P Cameron et al. Prehospital rapid sequence intubation improves functional outcome for patients with severe traumatic brain injury: a randomized controlled trial Ann Surg 252 2010 959 965
5. MG Lykissas, AV Korompilias, MD Vekris, GI Mitsionis, E Sakellariou, AE Beris The role of erythropoietin in central and peripheral nerve injury Clin Neurol Neurosurg 109 2007 639 644
6. T Coleman, M Brines Science review: recombinant human erythropoietin in critical illness: a role beyond anemia? Crit Care 8 2004 337 341
7. HM Bramlett, WD Dietrich Pathophysiology of cerebral ischemia and brain trauma: similarities and differences J Cereb Blood Flow Metab 24 2004 133 150
8. HL Corwin, A Gettinger, TC Fabian et al. Efficacy and safety of epoetin alfa in critically ill patients N Engl J Med 357 2007 965 976
9. CS Robertson, HJ Hannay, JM Yamal et al. Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury: a randomized clinical trial JAMA 312 2014 36 47
10. A Nichol, L Little, C French Erythropoietin for traumatic brain injury JAMA 312 2014 1928 1929
11. GM Teasdale, LE Pettigrew, JT Wilson, G Murray, B Jennett Analyzing outcome of treatment of severe head injury: a review and update on advancing the use of the Glasgow Outcome Scale J Neurotrauma 15 1998 587 597
12. A Nichol, C French, L Little et al. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial Trials 16 2015 39
13. Brain Trauma Foundation Guidelines for the management of severe traumatic brain injury J Neurotrauma 24 suppl 1 2007 S1 106
14. JT Wilson, LE Pettigrew, GM Teasdale Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use J Neurotrauma 15 1998 573 585
15. DJ Cook, G Rocker, M Meade et al. Prophylaxis of Thromboembolism in Critical Care (PROTECT) Trial: a pilot study J Crit Care 20 2005 364 372
16. J Presneill, L Little, A Nichol et al. Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury Trials 15 2014 501
17. EW Steyerberg, N Mushkudiani, P Perel et al. Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics PLoS Med 5 2008 e165
18. D Lu, A Mahmood, C Qu, A Goussev, T Schallert, M Chopp Erythropoietin enhances neurogenesis and restores spatial memory in rats after traumatic brain injury J Neurotrauma 22 2005 1011 1017
19. I Yatsiv, N Grigoriadis, C Simeonidou et al. Erythropoietin is neuroprotective, improves functional recovery, and reduces neuronal apoptosis and inflammation in a rodent model of experimental closed head injury FASEB J 19 2005 1701 1723
20. HL Corwin, A Gettinger, RG Pearl et al. Efficacy of recombinant human erythropoietin in critically ill patients: a randomized controlled trial JAMA 288 2002 2827 2835
21. AK Singh, L Szczech, KL Tang et al. Correction of anemia with epoetin alfa in chronic kidney disease N Engl J Med 355 2006 2085 2098
22. US Food and Drug Administration FDA strengthens safety information for erythropoietin-stimulating agents (ESAs) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108864.htm (accessed Sept 16, 2015).
23. HL Corwin Erythropoietin use in critically ill patients: forest and trees CMAJ 177 2007 747 749
24. PC Hebert, M Stanbrook Indication creep: physician beware CMAJ 177 2007 697
25. R Nirula, R Diaz-Arrastia, K Brasel, JA Weigelt, K Waxman Safety and efficacy of erythropoietin in traumatic brain injury patients: a pilot randomized trial Crit Care Res Pract 2010 2010 209848
26. S Aloizos, E Evodia, S Gourgiotis, E-C Isaia, C Seretis, GJ Baltipoulos Neuroprotective effects of erythropoietin in patients with severe closed brain injury Turk Neurosurg 25 2015 552 558
27. S Abrishamkar, M Safavi, A Honarmand Effect of erythropoietin on Glasgow Coma Scale and Glasgow Outcome Scale in patient with diffuse axonal injury J Res Med Sci 17 2012 51 56
28. BE Skolnick, AI Maas, RK Narayan et al. A clinical trial of progesterone for severe traumatic brain injury N Engl J Med 371 2014 2467 2476
29. DW Wright, SD Yeatts, R Silbergleit et al. Very early administration of progesterone for acute traumatic brain injury N Engl J Med 371 2014 2457 2466
30. HL Corwin, LM Napolitano Erythropoietin for critically ill trauma patients: a missed opportunity? J Trauma 77 2014 774 779