Rationale, methodology, and implementation of a nationwide multicenter randomized controlled trial of long-term mild hypothermia for severe traumatic brain injury (the LTH-1 trial)

Contemporary Clinical Trials

Volumn 40, Issue , 2015, Pages 9-14

  Lei, Jin ^a,b   Gao, Guoyi ^a,b   Mao, Qing ^a   Feng, Junfeng ^a   Wang, Lei ^a   You, Wendong ^a   Jiang, Jiyao ^a  

^a Shanghai Institute of Head Trauma   (China)

^b SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE   (China)

Author keywords

Efficacy; Long term mild hypothermia; Multicenter randomized trial; Safety; Severe traumatic brain injury

Indexed keywords

ADULT; AGED; ARTICLE; BODY TEMPERATURE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; FEMALE; FOLLOW UP; GLASGOW COMA SCALE; GLASGOW OUTCOME SCALE; HUMAN; INDUCED HYPOTHERMIA; INTRACRANIAL PRESSURE MONITORING; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PATIENT SAFETY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TRAUMATIC BRAIN INJURY; TREATMENT OUTCOME; BRAIN INJURIES; CHINA; CLINICAL PROTOCOL; CLINICAL TRIAL; INTRACRANIAL PRESSURE; METHODOLOGY; PROCEDURES;

BODY TEMPERATURE; BRAIN INJURIES; CHINA; CLINICAL PROTOCOLS; FEMALE; GLASGOW COMA SCALE; HUMANS; HYPOTHERMIA, INDUCED; INTRACRANIAL PRESSURE; LENGTH OF STAY; MALE; PROSPECTIVE STUDIES; RESEARCH DESIGN;

EID: 84919359432     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2014.11.008     Document Type: Article

References (31)

1. Faul M., Xu L., Wald M., Coronado V.G. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations and Deaths 2002-2006 2010, 2-70. Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Atlanta, GA.
2. Abelson-Mitchell N. Epidemiology and prevention of head injuries: literature review. J Clin Nurs 2008, 17:46-57.
3. Luerssen T.G., Klauber M.R., Marshall L.F. Outcome from head injury related to patient's age. A longitudinal prospective study of adult and pediatric head injury. J Neurosurg 1988, 68:409-416.
4. Adelson P.D., Ragheb J., Kanev P., Brockmeyer D., Beers S.R., Brown S.D., et al. Phase II clinical trial of moderate hypothermia after severe traumatic brain injury in children. Neurosurgery 2005, 56:740-754.
5. Maas A.I., Roozenbeek B., Manley G.T. Clinical trials in traumatic brain injury: past experience and current developments. Neurotherapeutics 2010, 7:115-126.
6. Lei J., Gao G., Jiang J. Acute traumatic brain injury: is current management evidence based? An empirical analysis of systematic reviews. J Neurotrauma 2013, 30:529-537.
7. Fay T. Observations on generalized refrigeration in cases of severe cerebral trauma. Assoc Res Nerv Ment Dis Proc 1943, 24:611-619.
8. Kramer C., Freeman W.D., Larson J.S., Hoffman-Snyder C., Wellik K.E., Demaerschalk B.M., et al. Therapeutic hypothermia for severe traumatic brain injury: a critically appraised topic. Neurologist 2012, 18:173-177.
9. Jiang J.Y. Clinical study of mild hypothermia treatment for severe traumatic brain injury. J Neurotrauma 2009, 26:399-406.
10. Maas A., Stocchetti N. Hypothermia and the complexity of trials in patients with traumatic brain injury. Lancet Neurol 2011, 10:111-113.
11. Clifton G.L., Miller E.R., Choi S.C., Levin H.S., McCauley S., Smith K.R., et al. Lack of effect of induction of hypothermia after acute brain injury. N Engl J Med 2001, 344:556-563.
12. Clifton G.L., Valadka A., Zygun D., Coffey C.S., Drever P., Fourwinds S., et al. Very early hypothermia induction in patients with severe brain injury (the National Acute Brain Injury Study: Hypothermia II): a randomised trial. Lancet Neurol 2011, 10:131-139.
13. Polderman K.H., Andrews P.J. Hypothermia in patients with brain injury: the way forward?. Lancet Neurol 2011, 10:404-405.
14. Stocchetti N., Colombo A., Ortolano F., Videtta W., Marchesi R., Longhi L., et al. Time course of intracranial hypertension after traumatic brain injury. J Neurotrauma 2007, 24:1339-1346.
15. Auer R.N. Non-pharmacologic (physiologic) neuroprotection in the treatment of brain ischemia. Ann N Y Acad Sci 2001, 939:271-282.
16. Ueda Y., Wei E.P., Kontos H.A., Suehiro E., Povlishock J.T. Effects of delayed, prolonged hypothermia on the pial vascular response after traumatic brain injury in rats. J Neurosurg 2003, 99:899-906.
17. Shann F. Hypothermia for traumatic brain injury: how soon, how cold, and how long?. Lancet 2003, 362:1950-1951.
18. Zweifler R.M., Voorhees M.E., Mahmood M.A., Alday D.D. Induction and maintenance of mild hypothermia by surface cooling in non-intubated subjects. J Stroke Cerebrovasc Dis 2003, 12:237-243.
19. Jiang J.Y., Xu W., Li W.P., Gao G.Y., Bao Y.H., Liang Y.M., et al. Effect of long-term mild hypothermia or short-term mild hypothermia on outcome of patients with severe traumatic brain injury. J Cereb Blood Flow Metab 2006, 26:771-776.
20. World Medical Association World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ 2011, 79:373-374.
21. Marion D.W., Penrod L.E., Kelsey S.F., Obrist W.D., Kochanek P.M., Palmer A.M., et al. Treatment of traumatic brain injury with moderate hypothermia. N Engl J Med 1997, 336:540-546.
22. Teasdale G., Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet 1974, 2:81-84.
23. Wilson J.T., Pettigrew L.E., Teasdale G.M. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma 1998, 15:573-585.
24. Jiang J., Yu M., Zhu C. Effect of long-term mild hypothermia therapy in patients with severe traumatic brain injury: 1-year follow-up review of 87 cases. J Neurosurg 2000, 93:546-549.
25. Polderman K.H. Induced hypothermia and fever control for prevention and treatment of neurological injuries. Lancet 2008, 371:1955-1969.
26. Nolan J.P., Deakin C.D., Soar J., Bottiger B.W., Smith G. European Resuscitation Council guidelines for resuscitation 2005. Section 4. Adult advanced life support. Resuscitation 2005, 67(Suppl. 1):S39-S86.
27. Shankaran S., Laptook A.R., Ehrenkranz R.A., Tyson J.E., McDonald S.A., Donovan E.F., et al. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med 2005, 353:1574-1584.
28. Marion D., Bullock M.R. Current and future role of therapeutic hypothermia. J Neurotrauma 2009, 26:455-467.
29. Shiozaki T., Nakajima Y., Taneda M., Tasaki O., Inoue Y., Ikegawa H., et al. Efficacy of moderate hypothermia in patients with severe head injury and intracranial hypertension refractory to mild hypothermia. J Neurosurg 2003, 99:47-51.
30. Andrews P.J., Sinclair H.L., Battison C.G., Polderman K.H., Citerio G., Mascia L., et al. European society of intensive care medicine study of therapeutic hypothermia (32-35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial). Trials 2011, 12:8.
31. Moore E.M., Nichol A.D., Bernard S.A., Bellomo R. Therapeutic hypothermia: benefits, mechanisms and potential clinical applications in neurological, cardiac and kidney injury. Injury 2011, 42:843-854.