Recombinant activated factor VII (rFVIIa) in the treatment of life threatening post-partum haemorrhage – data from the UniSeven clinical registry in the Czech Republic
Authors:
Seidlová Dagmar 1*; Blatný Jan 2*; Penka Miroslav 2; Ovesná Petra 4; Brabec Petr 4; Ševčík Pavel 1; Ventruba Pavel 5; Černý Vladimír 3
Authors‘ workplace:
Klinika anesteziologie, resuscitace a intenzivní medicíny a Anesteziologicko-resuscitační oddělení FN Brno
LF MU Brno
1; Oddělení klinické hematologie FN Brno, 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 Brno, LF MU Brno
5
Published in:
Anest. intenziv. Med., 21, 2010, č. 5, s. 229-238
Category:
Intensive Care Medicine - Original Paper
*Publikace má dva hlavní autory (D. Seidlová, J. Blatný), kteří se na jejím vypracování podíleli stejnou měrou.
Overview
Objective:
To analyze the data related to the treatment of 80 Czech patients with life threatening post-partum haemorrhage recorded in the UniSeven clinical registry in years 2004–2009.
Design:
Retrospective, observational, multicentre study.
Setting:
The ICUs and Obstetrics Departments of university and regional hospitals in the Czech Republic.
Materials and methods:
UniSeven is an international academic project of Masaryk University in Brno, Czech Republic, focused on the recording of clinical data related to the „off-label“ use of rFVIIa (Novo Seven) in life threatening bleeding. Data from 80 case reports of post-partum haemorrhage from the registry was analyzed from the clinical (efficacy and safety) and laboratory prospectives.
Results:
In 97.5 % of the patients the treatment with rFVIIa achieved control of the bleeding. In 53 women (66.3%) a single dose of rFVIIa was sufficient to control the bleeding. The rest of the patients received two or more rFVIIa doses. The first dose of rFVIIa given to the patients who needed more than one dose was significantly lower (96.6 µg/kg) compared to patients succesfully treated with a single dose (110.6 µg/kg; p = 0.048). The mortality rate in our cohort of patients was 2.5 %. We did not record any thrombo-embolic events related to the rFVIIa treatment. In the 74.3 % of patients where rFVIIa was administered before considering hysterectomy it was possible to avoid hysterectomy which we consider to be a significant improvement of the patients’ quality of life.
Conclusions:
Our data were considered during the preparation of the national guidelines for the treatment of life threatening post-partum haemorrhage in the Czech Republic.
Keywords:
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, K. S., Wojdyla, D., Say, L., Gulmezoglu, A. M., Van Look, P. F. WHO analysis of maternal death; a systematic review. Lancet, 2006, 367, p. 1066–1074.
3. Rodička a novorozenec 2008, 2007. Ústav zdravotnických informací a statistiky ČR.
4. Feyereisl, J. Závažné postpartální hemoragie a doporučený postup k léčbě. Česká gynekologie, 2008, 73, 6, p. 375–376.
5. Binder, T. Šokové stavy v porodnictví, Moderní porodnictví. Grada Publishing, a.s.: Praha 2008, p. 303–304.
6. Alfirevic, Z., Elbourne, D., Pavord, S., Bolte, A., Van Geijn, H., Mercier, F. 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., Farnia, A., Masse, B., Wetzl, R., Biachin, A., Rabi, A., Malacarne, P., Pasca, S., Bigotto, E. Use of recombinant activated factor VII in severe post-partum haemorrhage: Data from Italian Registry A multicentic observational retrospective study. Trombosis Research, 2009, 6, p. 41–47.
8. Roztočil, A. Nepravidelnosti III. doby porodní; Moderní porodnictví. Grada Publishing, a.s. : Praha 2008, p. 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, M. R. Guidelines for use of recombinant factor VIIa in life-threatening post-partum haemorrhage. International Journal of Obstetric Anesthesia, 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, D. M., Hoffman, M., Olivier, J. A., Roberts, H. R. 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. Journal of Biotechnology, 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, A. M., Tonda, R., Pino, M., Reverter, J. C., Ordinas, A., Escolar, G. 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., Pohlreichova, V., Smejkal, P., Cetkovsky, P., Dusek, L., Hedner, U. 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., Fiamoli, V., Penka, M., Smith, O. 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, 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., Luboshitz, J., Segal, E. 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, L. J. 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, S. A., Brun, N. C., 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, P. I., Eriksen, K., Nielsen, S. L., Rojkjaer, R., Alsbjorn, B. 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, J. P., Jonas, S., Jones, R. M. 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, R. P. et al. Factor VIIa for Correction of Traumatic Coagulopathy. J. Trauma, 2004, 57, 4, 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 Obstetricia et Gynecologica, 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, G. H., Platicanov, V., Tanchev, S., Kessler, C. M. Recombinant factor VIIa in the management of postpartum bleeds; an audit of clinical use. Acta Obstetrica et Gynecologica, 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. Česká gynekologie, 2005, 70, p. 144–148.
32. Mannová, J., Petrenko, M., Seidlová, D., Ondrášková, H., Mokrá, M., Zimová, I. Aktivovaný rekombinantní faktor VII u závažného poporodního krvácení: kazuistiky. Prakt. Gyn., 14, 2007, 4, p. 171–176.
33. Nadkarni, P. M., Brandt, C., Frawley, S., Sayward, F. G., Einbinder, R., Zelterman, D., Schacter, L., Miller, P. L. 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, P. M., Brandt, C. M., 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, P. M., 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, D. R. Trauma: Bleeding, Coagulopathy and Blood Component Transfusion. Yearbook of Intensive Care and Emergency Medicine, 2006, p. 255–264.
39. Vincent, J. L., Rossaint, R. B., Ozier, Y. Z. D. D., Spahn, D. R. Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding – a European perspective. Critical care, 2006, 10, 4, p. 120.
40. Blatný, J., Cvachovec, K., Černý, V., Kasal, E., Penka, M., Salaj, P., Višňa, P. Zásady podpory koagulace u život ohrožujícího a neztišitelného krvácení – konsensuální stanovisko. Anest. intenziv. Med., 2006, 6.
41. Hsia, C. C., Chin-Yee, I. H., McAlister, V. C. 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, J.-F., Belisle, S., Van der Linden, P. Efficasy Efficasy and Safety of Recombinant Activated factor VII to Control Bleeding in Nonhemophiliac Patients: A Rewiev of 17 Randomized Controlled. Trials Annals of Thoracic Surgery, 2008, 86, p. 1038–1048.
43. Binder, T., Cvachovec, K., Černý, V., Dulíček, P., Feyereisl, J., Kvasnička, J., Měchurová, A., Penka, M., Roztočil, A., Salaj, P., Seidlová, D., Ševčík, P., Valenta, J. Diagnostika a léčba akutního peripartálního život ohrožujícího krvácení – doporučený postup. Česká gynekologie, 2008, 73, 6, p. 377–379.
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Anaesthesiology and Intensive Care Medicine
2010 Issue 5
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