Dabigatran, intracranial hemorrhage, and the neurosurgeon hemorrhage

Neurosurgical Focus

Volumn 34, Issue 5, 2013, Pages

  Awad, Ahmed J ^a   Walcott, Brian P ^b   Stapleton, Christopher J ^b   Yanamadala, Vija ^b   Nahed, Brian V ^b   Coumans, Jean Valery ^b  

^a AN NAJAH NATIONAL UNIVERSITY   (Palestine)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

Dabigatran etexilate; Decompressive craniectomy; Fatal outcome; Pradaxa; Stroke; Tracheostomy; Warfarin

Indexed keywords

ANTITHROMBIN; BENZIMIDAZOLE DERIVATIVE; BETA ALANINE; DABIGATRAN; DRUG DERIVATIVE;

ANIMAL; BRAIN HEMORRHAGE; CASE REPORT; COMPUTER ASSISTED TOMOGRAPHY; FEMALE; HUMAN; METHODOLOGY; NEUROSURGERY; REVIEW; TREATMENT OUTCOME; VERY ELDERLY; ANALOGS AND DERIVATIVES; INTRACRANIAL HEMORRHAGES; PROCEDURES;

AGED, 80 AND OVER; ANIMALS; ANTITHROMBINS; BENZIMIDAZOLES; BETA-ALANINE; FEMALE; HUMANS; INTRACRANIAL HEMORRHAGES; NEUROSURGERY; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME;

EID: 84879030644     PISSN: None     EISSN: 10920684     Source Type: Journal    
DOI: 10.3171/2013.2.FOCUS1323     Document Type: Article

References (39)

1. Ahrens I, Lip GY, Peter K: New oral anticoagulant drugs in cardiovascular disease. Thromb Haemost 104:49-60, 2010
2. Berellini G, Springer C, Waters NJ, Lombardo F: In silico prediction of volume of distribution in human using linear and nonlinear models on a 669 compound data set. J Med Chem 52:4488-4495, 2009
3. Boehringer Ingelheim Pharmaceuticals: Highlights of prescribing information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, 2012 (http://bidocs.boehringer-ingelheim. com/BIWebAccess/ViewServlet.ser?docBase=renetnt& folderPath=/Prescribing%20Information/PIs/Pradaxa/ Pradaxa.pdf) [Accessed March 11, 2013]
4. Broderick J, Connolly S, Feldmann E, Hanley D, Kase C, Krieger D, et al: Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group. Stroke 38:2001-2023, 2007
5. Chang DN, Dager WE, Chin AI: Removal of dabigatran by hemodialysis. Am J Kidney Dis 61:487-489, 2013
6. Chen BC, Viny AD, Garlich FM, Basciano P, Howland MA, Smith SW, et al: Hemorrhagic complications associated with dabigatran use. Clin Toxicol (Phila) 50:854-857, 2012
7. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al: Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361:1139-1151, 2009
8. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L: Newly identified events in the RE-LY trial. N Engl J Med 363:1875-1876, 2010
9. Douxfils J, Mullier F, Robert S, Chatelain C, Chatelain B, Dogné JM: Impact of dabigatran on a large panel of routine or specific coagulation assays. Laboratory recommendations for monitoring of dabigatran etexilate. Thromb Haemost 107: 985-997, 2012
10. Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M: Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebocontrolled, crossover study in healthy subjects. Circulation 124:1573-1579, 2011
11. European Medicines Agency: European Medicines Agency updates on safety of Pradaxa.London: European Medicines Agency, 2011 (http://www.ema.europa.eu/ema/index.jsp ?curl=pages/news_and_events/news/2011/11/news_detail_ 001390.jsp&mid=WC0b01ac058004d5c1) [Accessed March 11, 2013]
12. Freyburger G, Macouillard G, Labrouche S, Sztark F: Coagulation parameters in patients receiving dabigatran etexilate or rivaroxaban: two observational studies in patients undergoing total hip or total knee replacement. Thromb Res 127:457- 465, 2011
13. Garber ST, Sivakumar W, Schmidt RH: Neurosurgical complications of direct thrombin inhibitors-catastrophic hemorrhage after mild traumatic brain injury in a patient receiving dabigatran. Case report. J Neurosurg 116:1093-1096, 2012
14. Granger CB, Alexander JH, McMurray JJV, Lopes RD, Hylek EM, Hanna M, et al: Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365:981-992, 2011
15. Harinstein LM, Morgan JW, Russo N: Treatment of dabigatran- associated bleeding: case report and review of the literature. J Pharm Pract [epub ahead of print], 2012
16. Hart RG, Diener HC, Yang S, Connolly SJ, Wallentin L, Reilly PA, et al: Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: the RELY trial. Stroke 43:1511-1517, 2012
17. Huang C, Siu M, Vu L, Wong S, Shin J: Factors influencing doctors' selection of dabigatran in non-valvular atrial fibrillation. J Eval Clin Pract [epub ahead of print], 2012
18. Khoo TL, Weatherburn C, Kershaw G, Reddel CJ, Curnow J, Dunkley S: The use of FEIBA(®) in the correction of coagulation abnormalities induced by dabigatran. Int J Lab Hematol [epub ahead of print], 2012
19. Liesenfeld KH, Schäfer HG, Trocóniz IF, Tillmann C, Eriksson BI, Stangier J: Effects of the direct thrombin inhibitor dabigatran on ex vivo coagulation time in orthopaedic surgery patients: a population model analysis. Br J Clin Pharmacol 62:527-537, 2006
20. Lindahl TL, Baghaei F, Blixter IF, Gustafsson KM, Stigendal L, Sten-Linder M, et al: Effects of the oral, direct thrombin inhibitor dabigatran on five common coagulation assays. Thromb Haemost 105:371-378, 2011
21. Moore TJ, Furberg CD, Cohen MR: Anticoagulants the Leading Reported Drug Risk in 2011. Alexandria, VA: Institute for Safe Medicine Practices, 2012 (http://www.ismp. org/quarterwatch/pdfs/2011Q4.pdf) [Accessed March 11, 2013]
22. Nowak G: The ecarin clotting time, a universal method to quantify direct thrombin inhibitors. Pathophysiol Haemost Thromb 33:173-183, 2003
23. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365:883-891, 2011
24. Pragst I, Zeitler SH, Doerr B, Kaspereit FJ, Herzog E, Dickneite G, et al: Reversal of dabigatran anticoagulation by prothrombin complex concentrate (Beriplex P/N) in a rabbit model. J Thromb Haemost 10:1841-1848, 2012
25. Schirmer SH, Baumhäkel M, Neuberger HR, Hohnloser SH, van Gelder IC, Lip GY, et al: Novel anticoagulants for stroke prevention in atrial fibrillation: current clinical evidence and future developments. J Am Coll Cardiol 56:2067-2076, 2010
26. Schulman S, Crowther MA: How I treat with anticoagulants in 2012: new and old anticoagulants, and when and how to switch. Blood 119:3016-3023, 2012
27. Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, et al: Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 361:2342- 2352, 2009
28. Siegal DM, Crowther MA: Acute management of bleeding in patients on novel oral anticoagulants. Eur Heart J 34:489- 498, 2012
29. Stangier J, Feuring M: Using the HEMOCLOT direct thrombin inhibitor assay to determine plasma concentrations of dabigatran. Blood Coagul Fibrinolysis 23:138-143, 2012
30. Stangier J, Rathgen K, Stähle H, Gansser D, Roth W: The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol 64:292-303, 2007
31. Stangier J, Rathgen K, Stähle H, Mazur D: Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single-centre study. Clin Pharmacokinet 49:259-268, 2010
32. US Food and Drug Administration: FDA approves Pradaxa to prevent stroke in people with atrial fibrillation. Silver Spring, MD: US Food and Drug Administration, 2010 (http:// www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm230241.htm) [Accessed March 11, 2013]
33. US Food and Drug Administration: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication-Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves.Silver Spring, MD: US Food and Drug Administration, 2012 (http://www.fda.gov/Safety/MedWatch/Safety Information/SafetyAlertsforHumanMedicalProducts/ucm 332949.htm?source=govdelivery) [Accessed March 11, 2013]
34. Van de Werf F, Brueckmann M, Connolly SJ, Friedman J, Granger CB, Hartter S, et al: A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: the randomized, phase II study to evaluate the safety and pharmacokinetics of oral dabigatran etexilate in patients after heart valve replacement (RE-ALIGN). Am Heart J 163: 931-937, 2012
35. van Ryn J, Litzenburger T, Waterman A, Canada K, Hauel N, Sarko C, et al: Dabigatran anticoagulant activity is neutralized by an antibody selective to dabigatran in in vitro and in vivo models. J Am Coll Cardiol 57:E1130, 2011
36. van Ryn J, Stangier J, Haertter S, Liesenfeld KH, Wienen W, Feuring M, et al: Dabigatran etexilate-a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 103:1116-1127, 2010
37. Wanek MR, Horn ET, Elapavaluru S, Baroody SC, Sokos G: Safe use of hemodialysis for dabigatran removal before cardiac surgery. Ann Pharmacother 46:e21, 2012
38. Weitz JI, Quinlan DJ, Eikelboom JW: Periprocedural management and approach to bleeding in patients taking dabigatran. Circulation 126:2428-2432, 2012
39. Zhou W, Schwarting S, Illanes S, Liesz A, Middelhoff M, Zorn M, et al: Hemostatic therapy in experimental intracerebral hemorrhage associated with the direct thrombin inhibitor dabigatran. Stroke 42:3594-3599, 2011