Assessment of effectiveness of major bleeding management: Proposed definitions for effective hemostasis: Communication from the SSC of the ISTH

Journal of Thrombosis and Haemostasis

Volumn 14, Issue 1, 2016, Pages 211-214

  Khorsand, N ^a,b   Majeed, A ^c   Sarode, R ^d   Beyer Westendorf, J ^e   Schulman, S ^c,f   Meijer, K ^a  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^b Central Hospital Pharmacy   (Netherlands)

^c KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^d UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^e UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^f MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; FIBRINOLYTIC AGENT;

ARTICLE; BLEEDING; BRAIN HEMORRHAGE; DRUG EFFICACY; HEMOSTASIS; HUMAN; MUSCULOSKELETAL BLEEDING; NON VISIBLE BLEEDING; PATIENT CARE; PRIORITY JOURNAL; STANDARDIZATION; TREATMENT OUTCOME; VISIBLE BLEEDING; CARDIOLOGY; DRUG EFFECTS; FIBRINOLYSIS; HEMORRHAGE; INTERNATIONAL COOPERATION; METHODOLOGY; PRACTICE GUIDELINE; STANDARDS;

ANTICOAGULANTS; CARDIOLOGY; FIBRINOLYSIS; FIBRINOLYTIC AGENTS; HEMORRHAGE; HEMOSTASIS; HUMANS; INTERNATIONAL COOPERATION; PRACTICE GUIDELINES AS TOPIC; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 84954525376     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.13148     Document Type: Article

References (34)

1. Khorsand N, Veeger NJ, van Hest RM, Ypma PF, Heidt J, Meijer K. An observational, prospective, two-cohort comparison of a fixed versus variable dosing strategy of prothrombin complex concentrate to counteract vitamin K antagonists in 240 bleeding emergencies. Haematologica 2012; 97: 1501-6.
2. Sarode R, Milling TJ Jr, Refaai MA, Mangione A, Schneider A, Durn BL, Goldstein JN. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation 2013; 128: 1234-43.
3. Majeed A, Eelde A, Agren A, Schulman S, Holmstrom M. Thromboembolic safety and efficacy of prothrombin complex concentrates in the emergency reversal of warfarin coagulopathy. Thromb Res 2012; 129: 146-51.
4. Khorsand N, Kooistra HA, van Hest RM, Veeger NJ, Meijer K. A systematic review of prothrombin complex concentrate dosing strategies to reverse vitamin K antagonist therapy. Thromb Res 2015; 135: 9-19.
5. Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692-4.
6. Goldstein JN, Refaai MA, Milling TJ Jr, Lewis B, Goldberg-Alberts R, Hug BA, Sarode R. Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet 2015; 385: 2077-87.
7. Broderick J, Connolly S, Feldmann E, Hanley D, Kase C, Krieger D, Mayberg M, Morgenstern L, Ogilvy CS, Vespa P, Zuccarello M. 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 - The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke 2007; 38: 2001-23.
8. Broderick JP, Brott TG, Duldner JE, Tomsick T, Huster G. Volume of intracerebral hemorrhage. A powerful and easy-to-use predictor of 30-day mortality. Stroke 1993; 24: 987-93.
9. Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, Khoury J. The ABCs of measuring intracerebral hemorrhage volumes. Stroke 1996; 27: 1304-5.
10. Bobbitt L, Merriman E, Raynes J, Henderson R, Blacklock H, Chunilal S. PROTHROMBINEX((R))-VF (PTX-VF) usage for reversal of coagulopathy: prospective evaluation of thrombogenic risk. Thromb Res 2011; 128: 577-82.
11. Cartmill M, Dolan G, Byrne JL, Byrne PO. Prothrombin complex concentrate for oral anticoagulant reversal in neurosurgical emergencies. Br J Neurosurg 2000; 14: 458-61.
12. Demeyere R, Gillardin S, Arnout J, Strengers PF. Comparison of fresh frozen plasma and prothrombin complex concentrate for the reversal of oral anticoagulants in patients undergoing cardiopulmonary bypass surgery: a randomized study. Vox Sang 2010; 99: 251-60.
13. Desmettre T, Dubart AE, Capellier G, Fanara B, Puyraveau M, Kepka S, Coquart J, Sheppard F, Tazarourte K. Emergency reversal of anticoagulation: the real use of prothrombin complex concentrates: a prospective multicenter two year French study from 2006 to 2008. Thromb Res 2012; 130: e178-83.
14. Dowlatshahi D, Butcher KS, Asdaghi N, Nahirniak S, Bernbaum ML, Giulivi A, Wasserman JK, Poon MC, Coutts SB. Poor prognosis in warfarin-associated intracranial hemorrhage despite anticoagulation reversal. Stroke 2012; 43: 1812-17.
15. Haghpanah S, Karimi M, Bordbar M, Kamfiroozi R, Asgharzadeh H. Experience on using prothrombin complex concentrate in urgent warfarin reversal: an Iranian survey. Clin Appl Thromb Hemost 2013; 19: 277-81.
16. Imberti D, Magnacavallo A, Dentali F, Condoleo E, Gallerani M, Benedetti R, Ageno W. Emergency reversal of anticoagulation with vitamin K antagonists with 3-factor prothrombin complex concentrates in patients with major bleeding. J Thromb Thrombolysis 2013; 36: 102-8.
17. Preston FE, Laidlaw ST, Sampson B, Kitchen S. Rapid reversal of oral anticoagulation with warfarin by a prothrombin complex concentrate (Beriplex): efficacy and safety in 42 patients. Br J Haematol 2002; 116: 619-24.
18. Roodheuvel F, Ligtenberg JJ, Ter Maaten JC. INR reduction after prothrombin complex concentrate (Co-fact(c)) administration: comparison of INR outcomes in different patient categories at the emergency department. Int J Emerg Med 2013; 6: 14-8.
19. Yasaka M, Sakata T, Naritomi H, Minematsu K. Optimal dose of prothrombin complex concentrate for acute reversal of oral anticoagulation. Thromb Res 2005; 115: 455-9.
20. Desmettre T, Dehours E, Samama CM, Jhundoo S, Pujeau F, Guillaudin C, Hecquart C, Clerson P, Crave JC, Jaussaud R. Reversal of vitamin K antagonist (VKA) effect in patients with severe bleeding: a French multicenter observational study (Optiplex) assessing the use of prothrombin complex concentrate (PCC) in current clinical practice. Crit Care 2012; 16: 185-96.
21. Evans G, Luddington R, Baglin T. Beriplex P/N reverses severe warfarin-induced overanticoagulation immediately and completely in patients presenting with major bleeding. Br J Haematol 2001; 115: 998-1001.
22. Lavenne-Pardonge E, Itegwa MA, Kalaai M, Klinkenberg G, Loncke JL, Pelgrims K, Strengers PF. Emergency reversal of oral anticoagulation through PPSB-SD: the fastest procedure in Belgium. Acta Anaesthesiol Belg 2006; 57: 121-5.
23. Lubetsky A, Hoffman R, Zimlichman R, Eldor A, Zvi J, Kostenko V, Brenner B. Efficacy and safety of a prothrombin complex concentrate (Octaplex) for rapid reversal of oral anticoagulation. Thromb Res 2004; 113: 371-8.
24. Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H, Barth J, Brand-Staufer B, Brenner B, Germann R, Griniute R, Haertel S, Kalina U, Katzel R, Kekstas G, Knaub S, Middeldorp S, Nagy A, Olah A, Ostermann H, et al. Prothrombin complex concentrate (Beriplex(registered trademark) P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost 2008; 6: 622-31.
25. Tran H, Chunilal S. Prothrombin complex concentrate safely reverses warfarin-related bleeding. Evid Based Med 2013; 19: 75.
26. van Aart L, Eijkhout HW, Kamphuis JS, Dam M, Schattenkerk ME, Schouten TJ, Ploeger B, Strengers PF. Individualized dosing regimen for prothrombin complex concentrate more effective than standard treatment in the reversal of oral anticoagulant therapy: an open, prospective randomized controlled trial. Thromb Res 2006; 118: 313-20.
27. Fischer M, Falkensammer C, Gauss P, Korp W, Kubiena K, Neubert J, Schnack H, Weissmann A. Administration of a new prothrombin complex concentrate in patients treated with anticoagulants and in patients with liver diseases. Med Welt 1973; 24: 1899-902.
28. Lorenz R, Kienast J, Otto U, Kiehl M, Schreiter D, Haertel S, Barthels M. Successful emergency reversal of phenprocoumon anticoagulation with prothrombin complex concentrate: a prospective clinical study. Blood Coagul Fibrinolysis 2007; 18: 565-70.
29. Kerebel D, Joly LM, Honnart D, Schmidt J, Galanaud D, Negrier C, Kursten F, Coriat P. A French multicenter randomised trial comparing two dose-regimens of prothrombin complex concentrates in urgent anticoagulation reversal. Crit Care 2013; 17: R4-15.
30. Riess HB, Meier-Hellmann A, Motsch J, Elias M, Kursten FW, Dempfle CE. Prothrombin complex concentrate (Octaplex) in patients requiring immediate reversal of oral anticoagulation. Thromb Res 2007; 121: 9-16.
31. Kuwashiro T, Yasaka M, Itabashi R, Nakagaki H, Miyashita F, Naritomi H, Minematsu K. Effect of prothrombin complex concentrate on hematoma enlargement and clinical outcome in patients with anticoagulant-associated intracerebral hemorrhage. Cerebrovasc Dis 2011; 31: 170-6.
32. Yasaka M, Sakata T, Minematsu K, Naritomi H. Correction of INR by prothrombin complex concentrate and vitamin K in patients with warfarin related hemorrhagic complication. Thromb Res 2002; 108: 25-30.
33. Vigue B, Ract C, Tremey B, Engrand N, Leblanc PE, Decaux A, Martin L, Benhamou D. Ultra-rapid management of oral anticoagulant therapy-related surgical intracranial hemorrhage. Intensive Care Med 2007; 33: 721-5.
34. Khorsand N, Veeger NJ, Muller M, Overdiek JW, Huisman W, van Hest RM, Meijer K. Fixed versus variable dose of prothrombin complex concentrate for counteracting vitamin K antagonist therapy. Transfus Med 2011; 21: 116-23.