Rekombinantní aktivovaný faktor VII (rFVIIa) v léčbě závažného poporodního krvácení
Data z registru UniSeven v České republice


Authors: D. Seidlová 1;  J. Blatný 2;  M. Penka 2;  P. Ovesná 4;  P. Brabec 4;  P. Ševčík 1;  P. Ventruba 5;  V. Černý 3
Authors‘ workplace: Klinika anesteziologie, resuscitace a intenzivní medicíny a Anesteziologicko-resuscitační oddělení FN, LF MU Brno 1;  Oddělení klinické hematologie FN, LF MU, Brno 2;  Klinika anesteziologie, resuscitace a intenzivní medicíny FN, Hradec Králové 3;  Institut biostatistiky a analýz Lékařské a Přírodovědecké fakulty MU, Brno 4;  Gynekologicko-porodnická klinika FN, LF MU, Brno 5
Published in: Ceska Gynekol 2010; 75(4): 297-305

Overview

Objective:
To analyze the data related to the treatment of 80 Czech patients with life threatening post-partum haemorrhage recorded in the clinical registry UniSeven during years 2004-2009.

Design:
Retrospective, observational, multicentre study.

Settings:
ICU and Obstetrics departments of University and Regional hospitals in Czech Republic.

Material and methods:
UniSeven is an international academic project of Masaryk University in Brno, Czech Republic, focused on recording of clinical data related to „off-label“ use of rFVIIa (Novo Seven) in life threatening bleeding. Data of 80 case reports of post partum haemorrhage from the registry was analysed from the clinical (efficacy and safety) as well as laboratory aspects.

Results:
In 97.5% of our patients the treatment with rFVIIa was able to control the bleeding. In 53 women (66.3%) only one dose of rFVIIa was sufficient to control the bleeding. The rest of the patient received two or more rFVIIa doses. First dose of rFVIIa given to patients who needed more than one dose was significantly lower (96.6 μg/kg) compared to patient succesfully treated with one dose only (110.6 μg/kg; p = 0.048). The mortality rate in our cohort of patients was 2.5%. We have not recorded any thrombembolic event as and adverse event related to the rFVIIa treatment. In 74.3% of patients where rFVIIa was administered before considering the hysterectomy, it was able to avoid hysterectomy what we consider to be a significant improvement of the patients‘ quality of life.

Conclusions:
Our data were also considered during the work up of national guidelines for the treatment of life threatening post-partum haemorrhage in the Czech Republic.

Key words:
post-partum haemorrhage, hysterectomy, rFVIIa, clinical registry.


Sources

1. Zhang, W., Alexander, S., Bouvier-Colle MacFarlane, A., MOMS-B Group. Incidence of severe pre-eclampsia, postpartum haemorrhage and sepsisas a surrogete marker of severe maternal morbidity in a European population-based study: the MOMS-B survey. BJOG 2005, 112, p. 89-96.

2. Khan, KS., Wojdyla, D., Say, L., et al. WHO analysis of maternal death; a systematic review. Lancet 2006, 367, p. 1066-1074.

3. Rodička a novorozenec 2008, 2007. Praha: Ústav zdravotnických informací a statistiky ČR.

4. Feyereisl, J. Závažné postpartální hemoragie a doporučený postup k léčbě. Čes Gynek 2008, 73, 6, p. 375-376.

5. Binder T. Šokové stavy v porodnictví. In Moderní porodnictví. Praha: Grada 2008, s. 303-304.

6. Alfirevic, Z., Elbourne, D., Pavord, S., et al. Use of recombinant activated factor VII in primary postpartum hemorrhagie. The northern european registry 2000-2004. Obst Gynecol 2007, 110, p. 1270-1278.

7. Barillari, G., Frigo, M., Casarotto, M., et al. Use of recombinant activated factor VII in severe post-partum haemorrhage: Data from Italian Registry A multicentic observational retrospective study. Trombosis Res 2009, 6, p. 41-47.

8. Roztočil, A. Nepravidelnosti III. doby porodní. In Moderní porodnictví. Praha: Grada 2008, s. 298-301, 307-309.

9. Franchini, M., et al. A critical review on the use of recombinant factor VIIa in life-threatening obstetric postpartum hemorrhage. Semin Thromb Hemost 2008, 34, p. 104–112.

10. Duffy, MR. Guidelines for use of recombinant factor VIIa in life-threatening post-partum haemorrhage. Inter J Obstet Anest 2007, 16, p. 299-300.

11. Hedner, U., et al. Successful use of recombinant factor VIIa in patient with severe haemophilia A during synovectomy. Lancet 1988, 2, p. 1193.

12. Ingerslev, J., Freidman, D., Gastineau, D., et al. Major surgery in haemophilic patients with inhibitors using recombinant factor VIIa. Haemostasis 1996, 26(Suppl. 1), p. 118–123.

13. Monroe, DM., Hoffman, M., Olivier, JA., Roberts, HR. Platelet activity of high-dose factor VIIa is independent of tissue factor. Br J Haematol 1997, 99, p. 642–647.

14. Hedner, U. Mechanism of action, development and clinical experience of recombinant FVIIa. J Biotechnol 2006, 124, p. 747–757.

15. Kjalke, M., et al. High-dose factor VIIa increases initial thrombin generation and mediates faster platelet activation in thrombocytopenia-like conditions in a cell-based model system. Br J Haematol 2001, 114, p. 114–120.

16. Galán, AM., Tonda, R., Pino, M., et al. Increased local procoagulant action: a mechanism contributing to the favorable hemostatic effect of recombinant FVIIa in PLT disorders. Transfusion 2006. 43, p. 885–891.

17. Salaj, P., Brabec, P,. Penka, M., et al. Effect of rFVIIa dose and time to treatment on patients with haemophilia and inhibitors: Analysis of HemoRec registry data from the Czech Republic, Haemophilia 2009, 15, p. 725-729.

18. Blatny, J., Kohlerova, S., Zapletal, O., et al. Prophylaxis with recombinant factor VIIa for the management of bleeding episodes during immune tolerance treatment in a boy with severe haemophilia A and inhibitors. Haemophilia 2008 Sep;14(5), p. 1140-1142.

19. Kenet, G., Walden, R., Eldad, A., Martinowitz, U. Treatment of traumatic bleeding with recombinant factor VIIa. Lancet 1999, 354(9193), p. 1879.

20. Martinowitz, U., Kenet, G., Lubetski, A., et al. Possible role of recombinant activated factor VII (rFVIIa) in the control of hemorrhage associated with massive trauma. Can J Anaesth 2002, 49, p. 15–20.

21. Bowman, LJ., et al. Use of recombinant activated factor VII concentrate to control postoperative hemorrhagie in complex cardiovascular surgery. Ann Thorac Surg 2008, 85, p. 1669–1677.

22. Mayer, SA., Brun, NC., Begtrup, K., et al. Recombinant activated factor VII intracerebral hemorrhage trial investigators: recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med 2005, 352, p. 777–785.

23. Johansson, PI., Eriksen, K., Nielsen, SL., et al. Recombinant FVIIa decreases perioperative blood transfusion requirement in burn patients undergoing excision and skin grafting—results of a single centre pilot study. Burns 2007, 33, p. 435–440.

24. Lodge, JP., Jonas, S., Jones, RM., et al. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl 2005, 11, p. 973–979.

25. Dutton, RP., et al. Factor VIIa for correction of traumatic coagulopathy. J Trauma 2004, 57, 4, p. 709-719.

26. Ahonen, J., Jokela, R. Recombinant factor VIIa for life-threatening post-partum haemorrhage. Br J Anaesth 2005, 94, p. 592–595.

27. Hosain, N., et al. Use of recombinant activated factor VII for massive postpartum hemorrhage. Acta Obstet Gynecol 2007, 86, p. 1200-1206.

28. Segal, S., et al. The use of recombinant factor VIIa in severe postpartum hemorrhage. Acta Obstet Gynecol Scand 2004, 83, p. 771–772.

29. Haynes, J., Laffan, M., Platt, F. Use of recombinant activated factor VII in massive obstetric haemorrhage. Int J Obstet Anesth 2007, 16, p. 40–49.

30. Sobieszczyk, S., Breborowiciz, GH., Platicanov, V., et al. Recombinant factor VIIa in the management of postpartum bleeds; an audit of clinical use. Acta Obstet Gynecol 2006, 85, p. 1239-1247.

31. Holub, Z., Feyereisl, J., Kabelik, L., Rittstein, T. Successful treatment of severe post-partum bleeding after caesarean section using recombinant activated factor VII. Čes Gynek 2005, 70, p. 144–148.

32. Mannová, J., Petrenko, M., Seidlová, D., a kol. Aktivovaný rekombinantní faktor VII u závažného poporodního krvácení: kazuistiky. Prakt Gyn 2007, 14, 4, s. 171–176.

33. Nadkarni, PM., Brandt, C., Frawley, S., et al. Managing attribute—value clinical trials data using the ACT/DB client-server database system. J Am Med Inform Assoc 1998, 5(2), p. 139-151.

34. Nadkarni, PM., Brandt, CM., Marenco, L. WebEAV: automatic metadata-driven generation of web interfaces to entity-attribute-value databases. J Am Med Inform Assoc 2000, 7(4), p. 343-356.

35. Nadkarni, PM., Marenco, L. Easing the transition between attribute-value databases and conventional databases for scientific data. Proc AMIA Symp 2001, p. 483-487.

36. Mayo, A., Martinowitz, U., Kluger, Y. Coagulopathy in the critically injured patient. Yearbook of Intensive Care and Emergency Medicine 2006, p. 232-243.

37. Chiara, O., Cimbanassi, S., Vesconi, S. Critical bleeding in blunt trauma patiens Yearbook of Intensive Care and Emergency Medicine 2006, p. 244-254.

38. Rossaint, R., Spahn, DR. Trauma: Bleeding, Coagulopathy and Blood Component Transfusion Yearbook of Intensive Care and Emergency Medicine 2006, p. 255-264.

39. Vincent, JL., Rossaint, RB., Ozier, YZDD., Spahn, DR. Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding - a European perspective. Critical care 2006, 4, 10, p. 120.

40. Blatný, J., Cvachovec, K., Černý, V., a kol. Zásady podpory koagulace u život ohrožujícího a neztišitelného krvácení – konsensuální stanovisko. Anest Intenzivní Med 2006, 6.

41. Hsia, CC., Chin-Yee, IH., McAlister, VC. Use of recombinant activated factor VII in patients without hemophilia. A meta-analysis of randomized control trials. Ann Surg 2008, 248, p. 61-68.

42. Hardy, JF., Belisle, S., Van der Linden, P. Efficasy and safety of recombinant activated factor VII to control bleeding in nonhemophiliac patients: A rewiev of 17 randomized controlled trials. Ann Thoracic Surg 2008, 86, p.1038-1048.

43. Binder, T., Cvachovec, K., Černý, V., a kol. Diagnostika a léčba akutního peripartálního život ohrožujícího krvácení – doporučený postup. Čes Gynek 2008, 73, 6, s. 377-379.

44. Rossaint, R., Bouillon, B., Cerny, V., et al. Management of bleeding following major trauma: an updated European guideline. Critical Care 2010 14, p. R52.

Labels
Paediatric gynaecology Gynaecology and obstetrics Reproduction medicine
Login
Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account