Recommendations and practices to optimize stroke therapy: Developing effective translational research programs

Stroke

Volumn 44, Issue 3, 2013, Pages 841-843

  Lapchak, Paul A ^a  

^a CEDARS SINAI MEDICAL CENTER   (United States)

Author keywords

Brain; Clinical trial; Hemorrhage; NIHSS; RIGOR; STAIR; Stroke; Translational

Indexed keywords

TISSUE PLASMINOGEN ACTIVATOR;

ARTICLE; BLOOD CLOT LYSIS; BRAIN HEMORRHAGE; BRAIN INFARCTION SIZE; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; CLINICAL RESEARCH; COST EFFECTIVENESS ANALYSIS; DIABETES MELLITUS; DIABETIC PATIENT; DISABILITY; DOSE RESPONSE; DRUG EFFICACY; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; HEART ATRIUM FIBRILLATION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; MORTALITY; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; PREDICTIVE VALUE; PRIORITY JOURNAL; QUALITY OF LIFE; TRANSLATIONAL RESEARCH; UNITED STATES;

HUMANS; NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE; PRACTICE GUIDELINES AS TOPIC; STROKE; TRANSLATIONAL MEDICAL RESEARCH; UNITED STATES;

EID: 84874819840     PISSN: 00392499     EISSN: 15244628     Source Type: Journal    
DOI: 10.1161/STROKEAHA.112.680439     Document Type: Article

References (33)

1. RIGOR. Improving the quality of NINDS-supported preclinical and clinical research through rigorous study design and transparent reporting. http://www.ninds.nih.gov/funding/transparency-in-reporting-guidance. pdf. 2012. Accessed January 1, 2013.
2. Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos A, Guidetti D, et al; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008;359:1317-1329.
3. Lansberg MG, Bluhmki E, Thijs VN. Efficacy and safety of tissue plasminogen activator 3 to 4.5 hours after acute ischemic stroke: a metaanalysis. Stroke. 2009;40:2438-2441.
4. Group ISTc, Sandercock P, Wardlaw JM, Lindley RI, Dennis M, Cohen G, et al. The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6 h of acute ischaemic stroke (the third international stroke trial [ist-3]): a randomised controlled trial. Lancet. 2012;379:2352-2363.
5. Fang MC, Cutler DM, Rosen AB. Trends in thrombolytic use for ischemic stroke in the United States. J Hosp Med. 2010;5:406-409.
6. Boudreau DM, Guzauskas G, Villa KF, Fagan SC, Veenstra DL. A model of cost-effectiveness of tissue plasminogen activator in patient subgroups 3 to 4.5 hours after onset of acute ischemic stroke. Ann Emerg Med. 2013; 61:46-55. http://dx.doi.org/10.1016/j.annemergmed.2012.04.020.
7. Kilkenny C, Browne W, Cuthill IC, Emerson M, Altman DG, National Center for the Replacement, Refinement and Reduction of Amimals in Research. Animal research: reporting in vivo experiments-the ARRIVE guidelines. J Cereb Blood Flow Metab. 2011;31:991-993.
8. Kilkenny C, Parsons N, Kadyszewski E, Festing MF, Cuthill IC, Fry D, et al. Survey of the quality of experimental design, statistical analysis and reporting of research using animals. PLoS ONE. 2009;4:e7824.
9. Bath PM, Gray LJ, Bath AJ, Buchan A, Miyata T, Green AR; NXY-059 Efficacy Meta-analysis in Individual Animals with Stroke Investigators. Effects of NXY-059 in experimental stroke: an individual animal metaanalysis. Br J Pharmacol. 2009;157:1157-1171.
10. Casals JB, Pieri NC, Feitosa ML, Ercolin AC, Roballo KC, Barreto RS, et al. The use of animal models for stroke research: a review. Comp Med. 2011;61:305-313.
11. Donnan GA. The 2007 Feinberg lecture: a new road map for neuroprotection. Stroke. 2008;39:242.
12. O'Collins VE, Donnan GA, Howells DW. History of animal models of stroke. Int J Stroke. 2011;6:77-78.
13. O'Collins VE, Macleod MR, Donnan GA, Horky LL, van der Worp BH, Howells DW. 1026 experimental treatments in acute stroke. Ann Neurol. 2006;59:467-477.
14. Traystman RJ. Animal models of focal and global cerebral ischemia. ILAR J. 2003;44:85-95.
15. Wiebers DO, Adams HP Jr, Whisnant JP. Animal models of stroke: are they relevant to human disease? Stroke. 1990;21:1-3.
16. Ginsberg MD. The validity of rodent brain-ischemia models is self-evident. Arch Neurol. 1996;53:1065-1067; discussion 1070.
17. Zivin JA, Grotta JC. Animal stroke models. They are relevant to human disease. Stroke. 1990;21:981-983.
18. Lapchak PA. Translational stroke research using a rabbit embolic stroke model: a correlative analysis hypothesis for novel therapy development. Transl Stroke Res. 2010;1:96-107.
19. Cook DJ, Tymianski M. Nonhuman primate models of stroke for translational neuroprotection research. Neurotherapeutics. 2012;9:371-379.
20. Petty GW, Brown RD Jr, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO. Ischemic stroke subtypes: a population-based study of incidence and risk factors. Stroke. 1999;30:2513-2516.
21. Petty GW, Brown RD Jr, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO. Ischemic stroke subtypes: a population-based study of functional outcome, survival, and recurrence. Stroke. 2000;31:1062-1068.
22. Fuentes B, Martínez-Sánchez P, de Leciñana MA, Egido J, Reig-Roselló G, Díaz-Otero F, et al; on behalf of the Madrid Stroke Network. Efficacy of intravenous thrombolysis according to stroke subtypes: the Madrid Stroke Network data. Eur J Neurol. 2012;19:1568-1574.
23. Tuttolomondo A, Pecoraro R, Pinto A, Licata G. A precise stroke classification for evaluation of ischemic stroke subtypes and their relation with diabetes: is TOAST the best? Stroke. 2011;42:e10.
24. Lapchak PA, Zhang JH. Resolving the negative data publication dilemma in translational stroke research. Transl Stroke Res. 2011;2:1-6.
25. Dirnagl U, Lauritzen M. Fighting publication bias: introducing the negative results section. J Cereb Blood Flow Metab. 2010;30:1263-1264.
26. Lapchak PA, Zhang JH, Noble-Haeusslein LJ. Rigor guidelines: escalating stairs and steps for effective translational research. Trans Stroke Res. 2012;doi:10.1007/s12975-012-0209-2.
27. STAIR. Recommendations for standards regarding preclinical neuroprotective and restorative drug development. Stroke. 1999;30:2752-2758.
28. Dirnagl U, Fisher M. International, multicenter randomized preclinical trials in translational stroke research: it's time to act. J Cereb Blood Flow Metab. 2012;32:933-935.
29. Lees KR, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener HC, et al.; Stroke-Acute Ischemic NXY Treatment (SAINT I) Trial Investigators. NXY-059 for acute ischemic stroke. N Engl J Med. 2006;354: 588-600.
30. Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, et al. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002;8:495-505.
31. Ehrenreich H, Weissenborn K, Prange H, Schneider D, Weimar C, Wartenberg K, et al.; EPO Stroke Trial Group. Recombinant human erythropoietin in the treatment of acute ischemic stroke. Stroke. 2009;40:e647-e656.
32. Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, et al; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007;357:562-571.
33. Landis SC, Amara SG, Asadullah K, Austin CP, Blumenstein R, Bradley EW, et al. A call for transparent reporting to optimize the predictive value of preclinical research. Nature. 2012;490:187-191.