| |
Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial
- 作者:Alistair Nichol (1) (2) (3) (4)
Craig French (5) (6) Lorraine Little (1) Jeffrey Presneill (1) (7) D James Cooper (1) (2) Samir Haddad (1) (8) Jacques Duranteau (1) (9) Olivier Huet (10) Markus Skrifvars (11) Yaseen Arabi (1) (12) Rinaldo Bellomo (1) (13) (6) On behalf of the EPO-TBI Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group
1. Australian and New Zealand Intensive Care Research Centre ; School of Public Health and Preventive Medicine ; Monash University ; 99 Commercial Road ; Melbourne ; 3004 ; Australia 2. Department of Intensive Care Medicine ; The Alfred ; Commercial Road ; Melbourne ; 3004 ; Australia 3. Department of Anaesthesia and Intensive Care Medicine ; St Vincent鈥檚 University Hospital ; Elm Park ; Dublin 4 ; Ireland 4. School of Medicine and Medical Sciences ; University College Dublin ; Elm Park ; Dublin 4 ; Ireland 5. Department of Intensive Care ; Western Health ; Gordon Street ; Footscray ; 3011 ; Australia 6. Department of Medicine North West Academic Centre ; The University of Melbourne ; Grattan Street ; Parkville ; 3052 ; Australia 7. Department of Intensive Care ; Mater Health Services ; Raymond Terrace ; South Brisbane ; 4101 ; Australia 8. Department of Intensive Care ; King Abdulaziz Medical City ; PO Box 22490 ; Riyadh ; 11426 ; Kingdom of Saudi Arabia 9. Service d鈥橝nesth茅sie-R茅animation ; H么pitaux universitaires Paris Sud ; Assistance Publique des H么pitaux de Paris ; H么pital de Bic锚tre ; 78 ; rue du G茅n茅ral Leclerc ; 94275 ; Le Kremlin Bic锚tre ; France 10. Department of Anesthesiology and Intensive Care Medicine ; Centre Hospitalier Universitaire La Cavale Blanche Universit茅 de Bretagne Ouest ; 29609 ; Brest Cedex ; France 11. Department of Anaesthesiology and Intensive Care Medicine ; Helsinki University Hospital ; PO Box 266 ; FIN-00029 ; Helsinki ; Finland 12. Intensive Care Department ; College of Medicine King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center ; PO Box 22490 ; Riyadh ; 11426 ; Kingdom of Saudi Arabia 13. Department of Intensive Care ; Austin Health ; Studley Road ; Heidelberg ; 3084 ; Australia
- 关键词:Traumatic brain injury ; Erythropoietin ; Outcome ; Critical care ; Randomised controlled trials
- 刊名:Trials
- 出版年:2015
- 出版时间:December 2015
- 年:2015
- 卷:16
- 期:1
- 全文大小:579 KB
- 参考文献:1. Access Economics. The economic cost of spinal cord injury and traumatic brain injury in Australia. Report by Access Economics Pty Limited for The Victorian Neurotrauma Initiative / . 2009; last access date 28 Jan 2015. href="http://www.tac.vic.gov.au/about-the-tac/our-organisation/research/tac-neurotrauma-research/vni/the20economic20cost20of20spinal20cord20injury20and20traumatic20brain20injury20in20australia.pdf" class="a-plus-plus">http://www.tac.vic.gov.au/about-the-tac/our-organisation/research/tac-neurotrauma-research/vni/the20economic20cost20of20spinal20cord20injury20and20traumatic20brain20injury20in20australia.pdf / .
2. Bramlett HM, Dietrich WD. Pathophysiology of cerebral ischemia and brain trauma: similarities and differences. J Cereb Blood Flow Metab. 2004;24:133鈥?0. href="http://dx.doi.org/10.1097/01.WCB.0000111614.19196.04" target="_blank" title="It opens in new window">CrossRef 3. Lykissas MG, Korompilias AV, Vekris MD, Mitsionis GI, Sakellariou E, Beris AE. The role of erythropoietin in central and peripheral nerve injury. Clin Neurol Neurosurg. 2007;109:639鈥?4. href="http://dx.doi.org/10.1016/j.clineuro.2007.05.013" target="_blank" title="It opens in new window">CrossRef 4. Coleman T, Brines M. Science review: recombinant human erythropoietin in critical illness: a role beyond anemia? Crit Care. 2004;8:337鈥?1. href="http://dx.doi.org/10.1186/cc2897" target="_blank" title="It opens in new window">CrossRef 5. Yatsiv I, Grigoriadis N, Simeonidou C, Stahel PF, Schmidt OI, Alexandrovitch AG, 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. 2005;19:1701鈥?. 6. Lu D, Mahmood A, Qu C, Goussev A, Schallert T, Chopp M. Erythropoietin enhances neurogenesis and restores spatial memory in rats after traumatic brain injury. J Neurotrauma. 2005;22:1011鈥?. href="http://dx.doi.org/10.1089/neu.2005.22.1011" target="_blank" title="It opens in new window">CrossRef 7. Corwin HL, Gettinger A, Pearl RG, Fink MP, Levy MM, Shapiro MJ, et al. Efficacy of recombinant human erythropoietin in critically ill patients: a randomized controlled trial. JAMA. 2002;288:2827鈥?5. href="http://dx.doi.org/10.1001/jama.288.22.2827" target="_blank" title="It opens in new window">CrossRef 8. Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, et al. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007;357:965鈥?6. href="http://dx.doi.org/10.1056/NEJMoa071533" target="_blank" title="It opens in new window">CrossRef 9. Abrishamkar S, Safavi M, Honarmand A. Effect of erythropoietin on Glasgow Coma Scale and Glasgow Outcome Sale in patient with diffuse axonal injury. J Res Med Sci. 2012;17:51鈥?. 10. Talving P, Lustenberger T, Inaba K, Lam L, Mohseni S, Chan L, et al. Erythropoiesis-stimulating agent administration and survival after severe traumatic brain injury: a prospective study. Arch Surg. 2012;147:251鈥?. href="http://dx.doi.org/10.1001/archsurg.2011.1838" target="_blank" title="It opens in new window">CrossRef 11. Tonia T, Mettler A, Robert N, Schwarzer G, Seidenfeld J, Weingart O, et al. Erythropoietin or darbepoetin for patients with cancer. Cochrane Database Syst Rev. 2012;12:CD003407. 12. Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006;355:2085鈥?8. href="http://dx.doi.org/10.1056/NEJMoa065485" target="_blank" title="It opens in new window">CrossRef 13. Teasdale GM, Pettigrew LE, Wilson JT, Murray G, Jennett B. Analyzing outcome of treatment of severe head injury: a review and update on advancing the use of the Glasgow Outcome Scale. J Neurotrauma. 1998;15:587鈥?7. href="http://dx.doi.org/10.1089/neu.1998.15.587" target="_blank" title="It opens in new window">CrossRef 14. Ware Jr J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220鈥?3. href="http://dx.doi.org/10.1097/00005650-199603000-00003" target="_blank" title="It opens in new window">CrossRef 15. EuroQol Group. EQ-5D鈩?instrument for describing and valuing health-related quality of life. 2014. Last access date 28 Jan 2015. href="http://www.euroqol.org/home.html" class="a-plus-plus">http://www.euroqol.org/home.html. 16. Cook DJ, Rocker G, Meade M, Guyatt G, Geerts W, Anderson D, et al. Prophylaxis of Thromboembolism in Critical Care (PROTECT) Trial: a pilot study. J Crit Care. 2005;20:364鈥?2. href="http://dx.doi.org/10.1016/j.jcrc.2005.09.010" target="_blank" title="It opens in new window">CrossRef 17. Vincent JL, Baron JF, Reinhart K, Gattinoni L, Thijs L, Webb A, et al. Anemia and blood transfusion in critically ill patients. JAMA. 2002;288:1499鈥?07. href="http://dx.doi.org/10.1001/jama.288.12.1499" target="_blank" title="It opens in new window">CrossRef 18. Corwin HL, Gettinger A, Pearl RG, Fink MP, Levy MM, Abraham E, et al. The CRIT Study: anemia and blood transfusion in the critically ill - current clinical practice in the United States. Crit Care Med. 2004;32:39鈥?2. href="http://dx.doi.org/10.1097/01.CCM.0000104112.34142.79" target="_blank" title="It opens in new window">CrossRef 19. Brain Trauma Foundation. Guidelines for the management of severe traumatic brain injury. J Neurotrauma. 2007;24 Suppl 1:S1鈥?06. 20. Marshall LF, Marshall SB, Klauber MR, Van Berkum CM, Eisenberg H, Jane JA, et al. The diagnosis of head injury requires a classification based on computed axial tomography. J Neurotrauma. 1992;9 Suppl 1:S287鈥?2. 21. Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998;15:573鈥?5. href="http://dx.doi.org/10.1089/neu.1998.15.573" target="_blank" title="It opens in new window">CrossRef 22. Fergusson D, Aaron SD, Guyatt G, Hebert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002;325:652鈥?. href="http://dx.doi.org/10.1136/bmj.325.7365.652" target="_blank" title="It opens in new window">CrossRef 23. Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, et al. Hydroxyethyl starch 130/0.42 versus Ringer鈥檚 acetate in severe sepsis. N Engl J Med. 2012;367:124鈥?4. href="http://dx.doi.org/10.1056/NEJMoa1204242" target="_blank" title="It opens in new window">CrossRef 24. Dijkers MP. Quality of life after traumatic brain injury: a review of research approaches and findings. Arch Phys Med Rehabil. 2004;85:S21鈥?5. href="http://dx.doi.org/10.1016/j.apmr.2003.08.119" target="_blank" title="It opens in new window">CrossRef 25. Bullinger M, Azouvi P, Brooks N, Basso A, Christensen AL, Gobiet W, et al. Quality of life in patients with traumatic brain injury-basic issues, assessment and recommendations. Restor Neurol Neurosci. 2002;20:111鈥?4. 26. Myburgh JA, Cooper DJ, Finfer SR, Venkatesh B, Jones D, Higgins A, et al. Epidemiology and 12-month outcomes from traumatic brain injury in Australia and New Zealand. J Trauma. 2008;64:854鈥?2. href="http://dx.doi.org/10.1097/TA.0b013e3180340e77" target="_blank" title="It opens in new window">CrossRef 27. Myburgh J, Cooper DJ, Finfer S, Bellomo R, Norton R, Bishop N, et al. Saline or albumin for fluid resuscitation in patients with traumatic brain injury. N Engl J Med. 2007;357:874鈥?4. href="http://dx.doi.org/10.1056/NEJMoa067514" target="_blank" title="It opens in new window">CrossRef 28. Hosmer DW, Lemeshow S, Sturdivant RX. Applied logistic regression. Hoboken, New Jersey: Wiley; 2013. href="http://dx.doi.org/10.1002/9781118548387" target="_blank" title="It opens in new window">CrossRef 29. Roozenbeek B, Lingsma HF, Perel P, Edwards P, Roberts I, Murray GD, et al. The added value of ordinal analysis in clinical trials: an example in traumatic brain injury. Crit Care. 2011;15:R127. href="http://dx.doi.org/10.1186/cc10240" target="_blank" title="It opens in new window">CrossRef 30. Cummings P. Re: converting an adjusted odds ratio to a risk ratio will produce biased estimates. BMJ. 2014; 348:f7450/rr/684808. 31. Grant RL. Converting an odds ratio to a range of plausible relative risks for better communication of research findings. BMJ. 2014;348:f7450. href="http://dx.doi.org/10.1136/bmj.f7450" target="_blank" title="It opens in new window">CrossRef 32. Norton EC, Miller MM, Kleinman LC. Computing adjusted risk ratios and risk differences in Stata. Stata J. 2013;13:492鈥?09. 33. Jennison C, Turnbull BW. Group sequential methods with applications to clinical trials. Boca Raton, Florida: Chapman & Hall/CRC; 2000. 34. Cook D, Lauzier F, Rocha MG, Sayles MJ, Finfer S. Serious adverse events in academic critical care research. CMAJ. 2008;178:1181鈥?. href="http://dx.doi.org/10.1503/cmaj.071366" target="_blank" title="It opens in new window">CrossRef
- 刊物主题:Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
- 出版者:BioMed Central
- ISSN:1745-6215
文摘
Background Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis. Methods/design The erythropoietin in traumatic brain injury trial is a stratified prospective, multi-centre, randomised, blinded, parallel-group, placebo-controlled phase III trial. It aims to determine whether the administration of erythropoietin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at six months after injury. The trial is designed to recruit 606 patients between 15 and 65 years of age with severe (Glasgow Coma Score: 3 to 8) or moderate (Glasgow Coma Score: 9 to 12) traumatic brain injury in Australia, New Zealand, Kingdom of Saudi Arabia, France, Finland, Germany and Ireland. Trial patients will receive either subcutaneous erythropoietin or placebo within 24 hours of injury, and weekly thereafter for up to three doses during the intensive care unit admission. The primary outcome will be the combined proportion of unfavourable neurological outcomes at six months: severe disability or death. Secondary outcomes will include the rate of proximal deep venous thrombosis detected by compression Doppler ultrasound, six-month mortality, the proportion of patients with composite vascular events (deep venous thrombosis, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at six months and quality of life with health economic evaluations. Discussion When completed, the trial aims to provide evidence on the efficacy and safety of erythropoietin in traumatic brain injury patients, and to provide clear guidance for clinicians in their management of this devastating condition. Trial registration Australian New Zealand Clinical Trials registry: ACTRN12609000827235 (registered on 22 September 2009). Clinicaltrials.gov: NCT00987454 (registered on 29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (registered on 18 January 2012).
| |
NGLC 2004-2010.National Geological Library of China All Rights Reserved.
Add:29 Xueyuan Rd,Haidian District,Beijing,PRC. Mail Add: 8324 mailbox 100083
For exchange or info please contact us via email.
| |