Skip to main content
Top
Published in: BMC Infectious Diseases 1/2007

Open Access 01-12-2007 | Case report

Failure of recombinant factor VIIa in a patient with severe polymicrobial sepsis and postoperative uncontrolled intraabdominal bleeding

Authors: Anna Conen, Maja Weisser, Dimitrios A Tsakiris, Martin Siegemund

Published in: BMC Infectious Diseases | Issue 1/2007

Login to get access

Abstract

Background

This report discusses a case of unsuccessful treatment with recombinant factor VIIa (rFVIIa) in off-label use. The need for international guidelines concerning the off-label use of rFVIIa is outlined as well as the need for methods to control the efficacy of rFVIIa objectively.

Case presentation

54 year old male with severe polymicrobial sepsis due to a perforated diverticulitis of the sigmoid colon and consecutive overt disseminated intravascular coagulation. He suffered severe intraabdominal bleeding after abdominal surgery despite conventional haemostatic support. Repeated applications of factor VIIa temporarily improved coagulation essays but did not stop clinical bleeding. The patient died in multiorgan failure due to septic and haemorrhagic shock.

Conclusion

Off-label use of rFVIIa could result in more side effects than could be expected from literature because of a publication bias. However for most off-label applications large prospective, randomised and controlled trials to confirm the positive findings are missing. For the future, not only guidelines concerning the off-label use of rFVIIa are urgently needed but also guidelines for monitoring the efficacy of rFVIIa.
Appendix
Available only for authorised users
Literature
1.
go back to reference Hedner U, Glazer S, Pingel K, Alberts KA, Blomback M, Schulman S, Johnsson H: Successful use of recombinant factor VIIa in patient with severe haemophilia A during synovectomy. Lancet. 1988, 2 (8621): 1193-10.1016/S0140-6736(88)90259-0.CrossRefPubMed Hedner U, Glazer S, Pingel K, Alberts KA, Blomback M, Schulman S, Johnsson H: Successful use of recombinant factor VIIa in patient with severe haemophilia A during synovectomy. Lancet. 1988, 2 (8621): 1193-10.1016/S0140-6736(88)90259-0.CrossRefPubMed
2.
go back to reference Macik BG, Hohneker J, Roberts HR, Griffin AM: Use of recombinant activated factor VII for treatment of a retropharyngeal hemorrhage in a hemophilic patient with a high titer inhibitor. Am J Hematol. 1989, 32 (3): 232-234. 10.1002/ajh.2830320315.CrossRefPubMed Macik BG, Hohneker J, Roberts HR, Griffin AM: Use of recombinant activated factor VII for treatment of a retropharyngeal hemorrhage in a hemophilic patient with a high titer inhibitor. Am J Hematol. 1989, 32 (3): 232-234. 10.1002/ajh.2830320315.CrossRefPubMed
3.
go back to reference Hedner U: Factor VIIa in the treatment of haemophilia. Blood Coagul Fibrinolysis. 1990, 1 (3): 307-317.CrossRefPubMed Hedner U: Factor VIIa in the treatment of haemophilia. Blood Coagul Fibrinolysis. 1990, 1 (3): 307-317.CrossRefPubMed
4.
go back to reference Ghorashian S, Hunt BJ: "Off-license" use of recombinant activated factor VII. Blood Rev. 2004, 18 (4): 245-259. 10.1016/j.blre.2003.12.003.CrossRefPubMed Ghorashian S, Hunt BJ: "Off-license" use of recombinant activated factor VII. Blood Rev. 2004, 18 (4): 245-259. 10.1016/j.blre.2003.12.003.CrossRefPubMed
5.
go back to reference Paganoni R: Off-label-Indikation von rekombinantem aktiviertem Faktor VII (rFVIIa, NovoSeven®), issued by Swiss Society for Intensive Care Medicine. 2005, www.swiss-icu.ch/NovoSeven_V07.pdf Paganoni R: Off-label-Indikation von rekombinantem aktiviertem Faktor VII (rFVIIa, NovoSeven®), issued by Swiss Society for Intensive Care Medicine. 2005, www.swiss-icu.ch/NovoSeven_V07.pdf
6.
go back to reference Martinowitz U, Michaelson M: Guidelines for the use of recombinant activated factor VII (rFVIIa) in uncontrolled bleeding: a report by the Israeli Multidisciplinary rFVIIa Task Force. J Thromb Haemost. 2005, 3 (4): 640-648. 10.1111/j.1538-7836.2005.01203.x.CrossRefPubMed Martinowitz U, Michaelson M: Guidelines for the use of recombinant activated factor VII (rFVIIa) in uncontrolled bleeding: a report by the Israeli Multidisciplinary rFVIIa Task Force. J Thromb Haemost. 2005, 3 (4): 640-648. 10.1111/j.1538-7836.2005.01203.x.CrossRefPubMed
7.
go back to reference Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T: Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2005, 352 (8): 777-785. 10.1056/NEJMoa042991.CrossRefPubMed Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T: Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2005, 352 (8): 777-785. 10.1056/NEJMoa042991.CrossRefPubMed
8.
go back to reference Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y: Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma. 2005, 59 (1): 8-15; discussion 15-8.CrossRefPubMed Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y: Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma. 2005, 59 (1): 8-15; discussion 15-8.CrossRefPubMed
9.
go back to reference Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B: Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005, 3 (9): 1935-1944. 10.1111/j.1538-7836.2005.01523.x.CrossRefPubMed Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B: Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005, 3 (9): 1935-1944. 10.1111/j.1538-7836.2005.01523.x.CrossRefPubMed
10.
go back to reference Planinsic RM, van der Meer J, Testa G, Grande L, Candela A, Porte RJ, Ghobrial RM, Isoniemi H, Schelde PB, Erhardtsen E, Klintmalm G, Emre S: Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease. Liver Transpl. 2005, 11 (8): 895-900. 10.1002/lt.20458.CrossRefPubMed Planinsic RM, van der Meer J, Testa G, Grande L, Candela A, Porte RJ, Ghobrial RM, Isoniemi H, Schelde PB, Erhardtsen E, Klintmalm G, Emre S: Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease. Liver Transpl. 2005, 11 (8): 895-900. 10.1002/lt.20458.CrossRefPubMed
11.
go back to reference Hedner U: Dosing and monitoring NovoSeven treatment. Haemostasis. 1996, 26 Suppl 1: 102-108.PubMed Hedner U: Dosing and monitoring NovoSeven treatment. Haemostasis. 1996, 26 Suppl 1: 102-108.PubMed
12.
go back to reference Stein DM, Dutton RP, O'Connor J, Alexander M, Scalea TM: Determinants of Futility of Administration of Recombinant Factor VIIa in Trauma. J Trauma. 2005, 59 (3): 609-615.PubMed Stein DM, Dutton RP, O'Connor J, Alexander M, Scalea TM: Determinants of Futility of Administration of Recombinant Factor VIIa in Trauma. J Trauma. 2005, 59 (3): 609-615.PubMed
13.
go back to reference Meng ZH, Wolberg AS, Monroe DM, Hoffman M: The effect of temperature and pH on the activity of factor VIIa: implications for the efficacy of high-dose factor VIIa in hypothermic and acidotic patients. J Trauma. 2003, 55 (5): 886-891.CrossRefPubMed Meng ZH, Wolberg AS, Monroe DM, Hoffman M: The effect of temperature and pH on the activity of factor VIIa: implications for the efficacy of high-dose factor VIIa in hypothermic and acidotic patients. J Trauma. 2003, 55 (5): 886-891.CrossRefPubMed
14.
go back to reference Clark AD, Gordon WC, Walker ID, Tait RC: 'Last-ditch' use of recombinant factor VIIa in patients with massive haemorrhage is ineffective. Vox Sang. 2004, 86 (2): 120-124. 10.1111/j.0042-9007.2004.00393.x.CrossRefPubMed Clark AD, Gordon WC, Walker ID, Tait RC: 'Last-ditch' use of recombinant factor VIIa in patients with massive haemorrhage is ineffective. Vox Sang. 2004, 86 (2): 120-124. 10.1111/j.0042-9007.2004.00393.x.CrossRefPubMed
15.
go back to reference Levi M: Disseminated intravascular coagulation: What's new?. Crit Care Clin. 2005, 21 (3): 449-467. 10.1016/j.ccc.2005.02.001.CrossRefPubMed Levi M: Disseminated intravascular coagulation: What's new?. Crit Care Clin. 2005, 21 (3): 449-467. 10.1016/j.ccc.2005.02.001.CrossRefPubMed
16.
go back to reference Moscardo F, Perez F, de la Rubia J, Balerdi B, Lorenzo JI, Senent ML, Aznar I, Carceller S, Sanz MA: Successful treatment of severe intra-abdominal bleeding associated with disseminated intravascular coagulation using recombinant activated factor VII. Br J Haematol. 2001, 114 (1): 174-176. 10.1046/j.1365-2141.2001.02878.x.CrossRefPubMed Moscardo F, Perez F, de la Rubia J, Balerdi B, Lorenzo JI, Senent ML, Aznar I, Carceller S, Sanz MA: Successful treatment of severe intra-abdominal bleeding associated with disseminated intravascular coagulation using recombinant activated factor VII. Br J Haematol. 2001, 114 (1): 174-176. 10.1046/j.1365-2141.2001.02878.x.CrossRefPubMed
17.
go back to reference Martinez J, Cid AR, de la Rubia J, Gimeno R: Treatment of intra-abdominal bleeding with recombinant activated factor VII in a patient with disseminated intravascular coagulation secondary to septic shock. Blood Coagul Fibrinolysis. 2005, 16 (4): 297-299.CrossRefPubMed Martinez J, Cid AR, de la Rubia J, Gimeno R: Treatment of intra-abdominal bleeding with recombinant activated factor VII in a patient with disseminated intravascular coagulation secondary to septic shock. Blood Coagul Fibrinolysis. 2005, 16 (4): 297-299.CrossRefPubMed
18.
go back to reference Sallah S, Husain A, Nguyen NP: Recombinant activated factor VII in patients with cancer and hemorrhagic disseminated intravascular coagulation. Blood Coagul Fibrinolysis. 2004, 15 (7): 577-582.PubMed Sallah S, Husain A, Nguyen NP: Recombinant activated factor VII in patients with cancer and hemorrhagic disseminated intravascular coagulation. Blood Coagul Fibrinolysis. 2004, 15 (7): 577-582.PubMed
19.
go back to reference Eller P, Pechlaner C, Wiedermann CJ: Ineffective off-label use of recombinant activated factor VII in a case of bone-marrow transplantation-related gastrointestinal bleeding. Thromb J. 2006, 4 (1): 1-10.1186/1477-9560-4-1.CrossRefPubMedPubMedCentral Eller P, Pechlaner C, Wiedermann CJ: Ineffective off-label use of recombinant activated factor VII in a case of bone-marrow transplantation-related gastrointestinal bleeding. Thromb J. 2006, 4 (1): 1-10.1186/1477-9560-4-1.CrossRefPubMedPubMedCentral
20.
go back to reference Levi M, Peters M, Buller HR: Efficacy and safety of recombinant factor VIIa for treatment of severe bleeding: a systematic review. Crit Care Med. 2005, 33 (4): 883-890. 10.1097/01.CCM.0000159087.85970.38.CrossRefPubMed Levi M, Peters M, Buller HR: Efficacy and safety of recombinant factor VIIa for treatment of severe bleeding: a systematic review. Crit Care Med. 2005, 33 (4): 883-890. 10.1097/01.CCM.0000159087.85970.38.CrossRefPubMed
21.
go back to reference O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM: Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. Jama. 2006, 295 (3): 293-298. 10.1001/jama.295.3.293.CrossRefPubMed O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM: Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. Jama. 2006, 295 (3): 293-298. 10.1001/jama.295.3.293.CrossRefPubMed
22.
go back to reference Pusateri AE, Park MS: Mechanistic implications for the use and monitoring of recombinant activated factor VII in trauma. Crit Care. 2005, 9 Suppl 5: S15-24. 10.1186/cc3781.CrossRefPubMed Pusateri AE, Park MS: Mechanistic implications for the use and monitoring of recombinant activated factor VII in trauma. Crit Care. 2005, 9 Suppl 5: S15-24. 10.1186/cc3781.CrossRefPubMed
23.
go back to reference Sorensen B, Ingerslev J: Tailoring haemostatic treatment to patient requirements - an update on monitoring haemostatic response using thrombelastography. Haemophilia. 2005, 11 Suppl 1: 1-6. 10.1111/j.1365-2516.2005.01156.x.CrossRefPubMed Sorensen B, Ingerslev J: Tailoring haemostatic treatment to patient requirements - an update on monitoring haemostatic response using thrombelastography. Haemophilia. 2005, 11 Suppl 1: 1-6. 10.1111/j.1365-2516.2005.01156.x.CrossRefPubMed
Metadata
Title
Failure of recombinant factor VIIa in a patient with severe polymicrobial sepsis and postoperative uncontrolled intraabdominal bleeding
Authors
Anna Conen
Maja Weisser
Dimitrios A Tsakiris
Martin Siegemund
Publication date
01-12-2007
Publisher
BioMed Central
Published in
BMC Infectious Diseases / Issue 1/2007
Electronic ISSN: 1471-2334
DOI
https://doi.org/10.1186/1471-2334-7-34

Other articles of this Issue 1/2007

BMC Infectious Diseases 1/2007 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine