Haemostatic therapies for acute spontaneous intracerebral haemorrhage

Cochrane Database of Systematic Reviews

Volumn 2018, Issue 4, 2018, Pages

  Al Shahi Salman, Rustam ^a   Law, Zhe Kang ^b,c   Bath, Philip M ^c   Steiner, Thorsten ^d,e   Sprigg, Nikola ^c  

^a UNIVERSITY OF EDINBURGH   (United Kingdom)

^b UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTER   (Malaysia)

^c UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^d UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^e UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOCAPROIC ACID; ANTIFIBRINOLYTIC AGENT; ANTITHROMBOCYTIC AGENT; BLOOD CLOTTING FACTOR; PLACEBO; RECOMBINANT BLOOD CLOTTING FACTOR 7A; TRANEXAMIC ACID; BLOOD CLOTTING FACTOR 7A; HEMOSTATIC AGENT; RECOMBINANT PROTEIN;

BRAIN HEMORRHAGE; DRUG EFFICACY; DRUG SAFETY; HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RANKIN SCALE; REGISTER; REVIEW; SCORING SYSTEM; SIDE EFFECT; SYSTEMATIC REVIEW; THROMBOCYTE TRANSFUSION; ACUTE DISEASE; ADULT; DISEASE EXACERBATION; HEMOSTASIS; META ANALYSIS; MORTALITY; PLASMA;

ACUTE DISEASE; ADULT; AMINOCAPROIC ACID; ANTIFIBRINOLYTIC AGENTS; CEREBRAL HEMORRHAGE; DISEASE PROGRESSION; FACTOR VIIA; HEMOSTASIS; HEMOSTATICS; HUMANS; PLASMA; PLATELET TRANSFUSION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS;

EID: 85045556886     PISSN: None     EISSN: 1469493X     Source Type: Journal    
DOI: 10.1002/14651858.CD005951.pub4     Document Type: Review

References (57)

1. Arumugam A, Rahman NAA, Theophilus SC, Shariffudin A, Abdullah JM. Tranexamic acid as antifibrinolytic agent in non traumatic intracerebral hemorrhages. Malaysian Journal of Medical Sciences 2015;December(Special issue):62-71. 7956486
2. Baharoglu MI, Cordonnier C, Al-Shahi Salman R, de Gans K, Koopman MM, Brand A, the PATCH Investigators. Platelet transfusion versus standard care after acute stroke due to spontaneous cerebral haemorrhage associated with antiplatelet therapy (PATCH): a randomised, open-label, phase 3 trial. Lancet 2016;387(10038):2605-13. 7956488
3. Gans K, de Haan RJ, Majoie CB, Koopman MK, Brand A, Dijkgraaf MG: the PATCH Investigators. PATCH: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial. BMC Neurology 2010;10:19. [Netherlands National Trial Register NTR1303]7956489
4. Boulis NM, Bobek MP, Schmaier A, Hoff JT. Use of factor IX complex in warfarin-related intracranial hemorrhage. Neurosurgery 1999;45(5):1113-8. 2778349
5. Novo Nordisk. Randomised, double-blind, multicentre, placebo controlled dose-escalation study to evaluate the safety and preliminary efficacy of activated recombinant factor VII (NN-007) in acute intracerebral haemorrhage. Unpublished 2007. [Novo Nordisk Trial ID F7ICH-1602]7956491
6. Imberti R, Pietrobono L, Klersy C, Gamba G, Iotti GA, Cornara G. Intraoperative intravenous administration of rFVIIa and hematoma volume after early surgery for spontaneous intracerebral hemorrhage: a randomized prospective phase II study. Minerva Anestesiologica 2012;78(2):168-75. 7956493
7. Li X, Wang YQ, Li W. Intervention study on recombinant activated factor VIIa in depressing early hematoma extensions of cerebral hemorrhage. Chinese Journal of New Drugs 2012;21(2):161-3. 2778352
8. Mayer SA, Brun NC, Broderick J, Davis S, Diringer MN, Skolnick BE, et al. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke 2005;36(1):74-9. 7956495
9. Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, et al. Recombinant activated factor VII for acute intracerebral hemorrhage. New England Journal of Medicine 2005;352(8):777-85. 7956497
10. Mayer SA, Brun NC, Broderick J, Davis SM, Diringer MN, Skolnick BE, et al. Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial. Neurocritical Care 2006;4(3):206-14. [Novo Nordisk Trial ID F7ICH-2073]7956499
11. Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, et al. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. New England Journal of Medicine 2008; Vol. 358, issue 20:2127-37. 7956501
12. Sprigg N, Renton C, Kwong Y, Dineen R, Bath PM. Tranexamic acid for acute intracerebral haemorrhage (TICH): results of the first randomised controlled trial. International Journal of Stroke 2012;7:7. 7956503
13. Sprigg N, Renton CJ, Dineen RA, Kwong Y, Bath PMW. Tranexamic acid for spontaneous intracerebral hemorrhage: a randomized controlled pilot trial. Journal of Stroke and Cerebrovascular Diseases 2014;23(6):1312-8. [ISRCTN50867461]7956504
14. Zazulia AR. Antifibrinolytic therapy in acute intracerebral hemorrhage - ATICH. www.strokecenter.org (accessed 27 November 2017). 7956506
15. Ciccone A, Brambilla G, Pozzi M, Roccatagliata D, Botto E, Gruccione A. Antifibrinolytic treatment of acute spontaneous intracerebral haemorrhage: rationale of the ANTITHESIS protocol. Proceedings of the Italian Stroke Forum. Florence, Italy, 2007:Abst. EMORR_03. 2778341
16. Kerebel D, Joly L-M, Honnart D, Schmidt J, Galanaud D, Negrier C, Lex206 Investigator Group. A French multicenter randomised trial comparing two dose-regimens of prothrombin complex concentrates in urgent anticoagulation reversal. Critical Care 2013;17:R4. 2778343
17. Li J-Y, Yuan L-X, Zhang G-M, Zhou L, Gao Y, Li Q-B, et al. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: a multi-center prospective randomized open-label blinded-endpoint trial. Chinese Journal of Integrative Medicine 2016;22(5):328-33. 7956508
18. Madjdinasab NN, Sharafaddinzadeh N, Mohamadianinejad E, Bavarsad R, Khakzadeh A. Effect of Novoseven on hospitalization duration of Iranian ICH patients. Cerebrovascular Diseases 2008;25(Suppl 2):158. 7956510
19. Meng L, Wu J, Zhou C. Auxiliary treatment of aprotinin on cerebral hemorrhage: clinical observation. Journal of Apoplexy and Nervous Diseases 2003;20(3):233-4. 2778345
20. NCT00222625. rFVIIa in ICH in patients treated with anticoagulants or anti-platelets. clinicaltrials.gov/ct2/show/NCT00222625 (first received 22 September 2005). 7956512
21. NCT02429453. FFP versus PCC in intracranial hemorrhage. clinicaltrials.gov/ct2/show/NCT02429453 (first received 29 April 2015). 7956514
22. Steiner T, Poli S, Griebe M, Hüsing J, Hajda J, Freiberger A, et al. Fresh frozen plasma versus prothrombin complex concentrate in patients with intracranial haemorrhage related to vitamin K antagonists (INCH): a randomised trial. Lancet Neurology 2016;15(6):566-73. 7956516
23. Zhou C, Wu J, Meng L. Mechanism of aprotinin in auxiliary treatment of cerebral hemorrhage. Chinese Journal of Neurology 2005;38(1):22-4. 2778347
24. Liu L, Wang Y, Meng X, Li N, Tan Y, Nie X, et al. the TRAIGE investigators. Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: rationale and design. International Journal of Stroke 2017;12(3):326-31. 7956518
25. Meretoja A, Churilov L, Campbell BCV, Aviv RI, Yassi N, Barras C, et al. The Spot sign and Tranexamic acid On Preventing ICH growth - AUStralasia Trial (STOP-AUST): protocol of a phase II randomized, placebo-controlled, double-blind, multicenter trial. International Journal of Stroke 2014;9(4):519-24. 7956520
26. NCT00699621. Platelet transfusion in acute intracerebral hemorrhage. clinicaltrials.gov/ct2/show/NCT00699621 (first received 18 June 2008). 7956522
27. NCT00810888. The Spot Sign for predicting and treating ICH growth study (STOP-IT). clinicaltrials.gov/ct2/show/NCT00810888 (first received 18 December 2008). 7956524
28. NCT01359202. 'Spot Sign' selection of intracerebral hemorrhage to guide hemostatic therapy (SPOTLIGHT). clinicaltrials.gov/ct2/show/NCT01359202 (first received 24 May 2011). 7956526
29. NCT02777424. Prothrombin complex concentrate versus fresh frozen plasma to correct coagulation disorders in adult neurosurgical patients (CLOT-CRANE). clinicaltrials.gov/ct2/show/NCT02777424 (first received 19 May 2016). 7956528
30. NCT02866838. Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist (TICH-NOAC). clinicaltrials.gov/ct2/show/NCT02866838 (first received 15 August 2016). 7956530
31. NCT03044184. Tranexamic acid for spontaneous acute cerebral hemorrhage trial (TRANSACT). clinicaltrials.gov/ct2/show/NCT03044184 (first received 6 February 2017). 7956532
32. The Norwegian Intracerebral Hemorrhage Trial (NOR-ICH). helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?p_document_id=324797 (first received 1 March 2013). 7956534
33. Sprigg N, Robson K, Bath P, Dineen R, Roberts I, Robinson T, for the TICH-2 Investigators. Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial. International Journal of Stroke 2016;11(6):717-23. 7956536
34. Al-Shahi Salman R, Labovitz DL, Stapf C. Spontaneous intracerebral haemorrhage. BMJ 2009;339:b2586.
35. Brott T, Broderick J, Kothari R, Barsan W, Tomsick T, Sauerbeck L, et al. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke 1997;28(1):1-5.
36. Dastur YK, Wengui Y. Current management of spontaneous intracerebral haemorrhage. Stroke and Vascular Neurology 2017;2(1):21-9.
37. Davis SM, Broderick J, Hennerici M, Brun NC, Diringer MN, Mayer SA, et al. Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage. Neurology 2006;66(8):1175-81.
38. Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurology 2009;8(4):355-69.
39. Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, et al. Update on the global burden of ischemic and hemorrhagic stroke in 1990-2013: the GBD 2013 Study. Neuroepidemiology 2015;45(3):161-76.
40. Hemphill JC, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, the American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, and Council on Clinical Cardiology. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2015;46(7):2032-60.
41. Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
42. Iorio. Personal communication (email) 9th April 2012.
43. Johansen M, Wikkelsø A, Lunde J, Wetterslev J, Afshari A. Prothrombin complex concentrate for reversal of vitamin K antagonist treatment in bleeding and non-bleeding patients. Cochrane Database of Systematic Reviews 2015, Issue 7. [DOI: 10.1002/14651858.CD010555.pub2]
44. Ker K, Roberts I, Shakur H, Coats TJ. Antifibrinolytic drugs for acute traumatic injury. Cochrane Database of Systematic Reviews 2015, Issue 5. [DOI: 10.1002/14651858.CD004896.pub4]
45. Lovelock CE, Molyneux AJ, Rothwell PM, Oxford Vascular Study. Change in incidence and aetiology of intracerebral haemorrhage in Oxfordshire, UK, between 1981 and 2006: a population-based study. Lancet Neurology 2007;6(6):487-93.
46. Mayer SA. Personal communication (discussion at the European Stroke Conference, Glasgow, UK 2007.
47. Poon MT, Fonville AF, Al-Shahi Salman R. Long-term prognosis after intracerebral haemorrhage: systematic review and meta-analysis. Journal of Neurology, Neurosurgery and Psychiatry 2014;85(6):660-7.
48. Prasad K, Mendelow AD, Gregson B. Surgery for primary supratentorial intracerebral haemorrhage. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD000200.pub2]
49. Intercollegiate Stroke Working Party. National Clinical Guideline for Stroke. Fifth. London: Royal College of Physicians, 2016.
50. Samarasekera N, Fonville A, Lerpiniere C, Farrall AJ, Wardlaw JM, White PM, the Lothian Audit of the Treatment of Cerebral Haemorrhage Collaborators. Influence of intracerebral hemorrhage location on incidence, characteristics, and outcome: population-based study. Stroke 2015;46(3):361-8.
51. Simpson E, Lin Y, Stanworth S, Birchall J, Doree C, Hyde C. Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. Cochrane Database of Systematic Reviews 2012, Issue 2. [DOI: 10.1002/14651858.CD005011.pub4]
52. Steiner T, Al-Shahi Salman R, Beer R, Christensen H, Cordonnier C, Csiba L, et al. European Stroke Organisation (ESO) guidelines for the management of spontaneous intracerebral hemorrhage. International Journal of Stroke 2014;9(7):840-55.
53. Wikkelsø A, Lunde J, Johansen M, Stensballe J, Wetterslev J, Møller AM, et al. Fibrinogen concentrate in bleeding patients. Cochrane Database of Systematic Reviews 2013, Issue 8. [DOI: 10.1002/14651858.CD008864.pub2]
54. Zazulia. Personal communication email 1, 15, 30 Nov 2005 2005.
55. Al-Shahi R, You H. Hemostatic drug therapies for acute, nontraumatic intracerebral hemorrhage. Stroke 2007;38:204-5.
56. Al-Shahi Salman R. Haemostatic drug therapies for acute spontaneous intracerebral haemorrhage. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD005951.pub3]
57. You H, Al-Shahi Salman R. Haemostatic drug therapies for acute primary intracerebral haemorrhage. Cochrane Database of Systematic Reviews 2006, Issue 3. [DOI: 10.1002/14651858.CD005951.pub2]