CRASH-2 (Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage) Intracranial Bleeding Study: The effect of tranexamic acid in traumatic brain injury - a nested, randomised, placebo-controlled trial

Health Technology Assessment

Volumn 16, Issue 13, 2012, Pages

  Perel, P ^a   Al Shahi Salman, R ^b   Kawahara, T ^a   Morris, Z ^b   Prieto Merino, D ^a   Roberts, I ^a   Sandercock, P ^b   Shakur, H ^a   Wardlaw, J ^b  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^b WESTERN GENERAL HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TRANEXAMIC ACID; ANTIARRHYTHMIC AGENT; ANTIFIBRINOLYTIC AGENT;

ARTICLE; BRAIN CONTUSION; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; EPIDURAL HEMATOMA; FEMALE; GLASGOW COMA SCALE; HUMAN; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROIMAGING; OUTCOME ASSESSMENT; PETECHIA; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SUBARACHNOID HEMORRHAGE; SUBDURAL HEMATOMA; TRAUMATIC BRAIN INJURY; UNSPECIFIED SIDE EFFECT; ADULT; CONTROLLED CLINICAL TRIAL; MIDDLE AGED; PATHOPHYSIOLOGY; RADIOGRAPHY; RISK; YOUNG ADULT;

ADULT; ANTI-ARRHYTHMIA AGENTS; ANTIFIBRINOLYTIC AGENTS; FEMALE; GLASGOW COMA SCALE; HUMANS; INTRACRANIAL HEMORRHAGE, TRAUMATIC; MALE; MIDDLE AGED; ODDS RATIO; OUTCOME ASSESSMENT (HEALTH CARE); PROSPECTIVE STUDIES; TRANEXAMIC ACID; YOUNG ADULT;

EID: 84859136754     PISSN: 13665278     EISSN: 20464924     Source Type: Journal    
DOI: 10.3310/hta16130     Document Type: Article

References (32)

1. Menon DK, Schwab K, Wright DW, Maas AI. Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health. Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil 2010;91:1637-40.
2. Bruns J, Jr, Hauser WA. The epidemiology of traumatic brain injury: a review. Epilepsia 2003;44(Suppl. 10):2-10.
3. CRASH trial Collaborators. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months. Lancet 2005;365:1957-9.
4. Perel P, Roberts I, Bouamra O, Woodford M, Mooney J, Lecky F. Intracranial bleeding in patients with traumatic brain injury: a prognostic study. BMC Emerg Med 2009;9:15.
5. Oertel M, Kelly DF, McArthur D, Boscardin WJ, Glenn TC, Lee JH, et al. Progressive hemorrhage after head trauma: predictors and consequences of the evolving injury. J Neurosurg 2002;96:109-16.
6. Yadav YR, Basoor A, Jain G, Nelson A. Expanding traumatic intracerebral contusion/hematoma. Neurol India 2006;54:377-81.
7. Sullivan TP, Jarvik JG, Cohen WA. Follow-up of conservatively managed epidural hematomas: implications for timing of repeat CT. Am J Neuroradiol 1999;20:107-13.
8. Narayan RK, Maas AI, Servadei F, Skolnick BE, Tillinger MN, Marshall LF. Progression of traumatic intracerebral hemorrhage: a prospective observational study. J Neurotrauma 2008;25:629-39.
9. Prentice CR. Basis of antifibrinolytic therapy. J Clin Pathol Suppl 1980;14:35-40.
10. Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McClelland B, et al. Antifibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev 2007;4:CD001886.
11. Harhangi BS, Kompanje EJ, Leebeek FW, Maas AI. Coagulation disorders after traumatic brain injury. Acta Neurochir 2008;150:165-75.
12. Bayir A, Kalkan E, Koçak S, Ak A, Cander B, Bodur S. Fibrinolytic markers and neurologic outcome in traumatic brain injury. Neurol India 2006;54:363-5.
13. Perel P, Roberts I, Shakur H, Thinkhamrop B, Phuenpathom N, Yutthakasemsunt S. Haemostatic drugs for traumatic brain injury. Cochrane Database Syst Rev 2010;1:CD007877.
14. Roos YB, Rinkel GJ, Vermeulen M, Algra A, van Gijn J. Antifibrinolytic therapy for aneurysmal subarachnoid haemorrhage. Cochrane Database Syst Rev 2003;2:CD001245.
15. Stein SC, Halpern C, Reilly PM. Upsetting the balance. Indian J Med Res 2007;125:186-7.
16. CRASH-2 trial collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet 2010;376:23-32.
17. Peto R, Baigent C. Trials: the next 50 years. BMJ 1998;317:1170-1.
18. Wardlaw JM, Easton VJ, Statham P. Which CT features help predict outcome after head injury? J Neurol Neurosurg Psychiatry 2002;72:188-92.
19. Osborn A. Diagnostic imaging: brain. Altona, MB: Amirsys; 2004.
20. Kwak R, Kadoya S, Suzuki T. Factors affecting the prognosis in thalamic hemorrhage. Stroke 1983;14:493-500.
21. Gebel JM, Sila CA, Sloan MA, Granger CB, Weisenberger JP, Green CL, et al. Comparison of the ABC/2 estimation technique to computer-assisted volumetric analysis of intraparenchymal and subdural haematomas complicating the GUSTO-1 trial. Stroke 1998;29:1799-801.
22. Petersen OF, Espersen JO. Extradural hematomas: measurement of size by volume summation on CT scanning. Neuroradiology 2004;26:363-7.
23. Greene KA, Marciano FF, Johnson BA, Jacobowitz R, Spetzler RF, Harrington TR. Impact of traumatic subarachnoid hemorrhage on outcome in nonpenetrating head injury. Part I: a proposed computerized tomography grading scale. J Neurosurg 1995;83:445-52.
24. Hijdra A, Brouwers PJAM, Vermeulen M, van Gijn J. Grading the amount of blood on computed tomograms after subarachnoid hemorrhage. Stroke 1990;21:1156-61.
25. Wardlaw JM, Sellar RJ. A simple practical classification of cerebral infarcts on CT and its interobserver reliability. Am J Neuroradiol 1994;15:1933-9.
26. Perel P, Edwards P, Shakur H, Roberts I. Use of the Oxford Handicap Scale at hospital discharge to predict Glasgow Outcome Scale at 6 months in patients with traumatic brain injury. BMC Med Res Methodol 2008;8:72.
27. Spiegelhalter DJ, Abrahms KR, Myles JP. Bayesian approaches to clinical trials and health care evaluation. Chichester: John Wiley; 2004.
28. Perel P, for the MRC CRASH Collaborators. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ 2008;336:425-9.
29. Pathak A, Dutta S, Marwaha N, Singh D, Varma N, Mathuriya SN. Change in tissue thromboplastin content of brain following trauma. Neurol India 2005;53:178-82.
30. Cohen MJ, Brohi K, Ganter MT, Manley GT, Mackersie RC, Pittet JF. Early coagulopathy after traumatic brain injury: the role of hypoperfusion and the protein C pathway. J Trauma 2007;63:1254-61.
31. Lustenberger T, Talving P, Kobayashi L, Barmparas G, Inaba K, Lam L, et al. Early coagulopathy after isolated severe traumatic brain injury: relationship with hypoperfusion challenged. J Trauma 2010;69:1410-14.
32. Astrup J. ['Ultra-early' antifibrinolytic treatment of subarachnoidal bleeding with tranexamic acid.] Ugeskr Laeger 2006;168:1107-11.