Ineffective off-label use of recombinant activated factor VII in a case of bone-marrow transplantation-related gastroint
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BioMed Central
Open Access
Case report
Ineffective off-label use of recombinant activated factor VII in a case of bone-marrow transplantation-related gastrointestinal bleeding P Eller1, C Pechlaner1 and CJ Wiedermann*2 Address: 1Division of General Internal Medicine, Department of Medicine, Medical University of Innsbruck, Anichstrasse 35, A-6020 Innsbruck, Austria and 22nd Division of Internal Medicine, Department of Medicine, Central Hospital of Bolzano, Lorenz Boehler Street 5, I-39100 Bolzano (BZ), Italy Email: P Eller - [email protected]; C Pechlaner - [email protected]; CJ Wiedermann* - [email protected] * Corresponding author
Published: 18 January 2006 Thrombosis Journal 2006, 4:1
doi:10.1186/1477-9560-4-1
Received: 28 October 2005 Accepted: 18 January 2006
This article is available from: http://www.thrombosisjournal.com/content/4/1/1 © 2006 Eller et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract Background: For patients with a normal coagulation system, who experience serious bleeding, sound evidence for recombinant activated factor VII (rFVIIa) as an effective haemostatic agent is only scarcely available so far from controlled clinical trials. In systematic reviews on the clinical use of rFVIIa, treatment failures were only rarely reported. Case presentation: We present a 45-year old, Caucasian male with persistent intestinal bleeding due to enterocolitis associated with cytomegalovirus infection and acute graft-versus-host-disease. He had received allogeneic peripheral blood stem cell transplantation from an unrelated HLAidentical donor because of chronic myelogenous leukaemia diagnosed two years earlier. Bleeding started at day 18 after transplantation with bloody diarrhea, which was treated with multiple transfusions of fresh frozen plasma, platelet, and red blood cell concentrates, and continued relentlessly, despite all efforts, including continued transfusions, high-dose prednisolone, broad antibiotic and antiviral coverage, and tranexamic acid. Recombinant FVIIa was started at boluses of 90–120 µg/kg every 4–8 hours. Despite more than 10 doses, recurrent severe bleeding progressed to refractory shock, multiorgan failure and death. Conclusions: Little can be concluded from single case reports of clinical improvement, because publication bias in favour of positive effects is likely. Our case suggests that rFVIIa is not a panacea, in particular for severe bleeding after bone-marrow transplantation. As long as rigorous, controlled studies or comprehensive registries are lacking, conventional interventions remain the standard of care in non-haemophilic patients with severe bleeding.
Introduction Recombinant activated factor VII (rFVIIa) is an effective haemostatic agent in approximately 90% of patie
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