I read with high interest the case report by Konstantinos Vlachos and colleagues entitled "Successful use of recombinant factor VII for postoperative associated hemorrhage" (Cases Journal 2008, 1:361).
The authors have to be congratulated for their excellent management of a coagulopathic patient with massive postoperative bleeding secondary to a renal biopsy.
However, I was disappointed regarding the adequacy of the work-up of the pertinent, peer-reviewed literature in the field. The authors state that "published clinical experiences for the use of rFVIIa in trauma are limited to small series and case reports" (abstract) and "data supporting the use of rFVIIa within trauma have been limited to case series and anecdotal reports" (conclusion).
These statements are inaccurate and highly misleading.
Multiple prospective studies, including double-blind randomized trials, as well as meta-analyses, systematic reviews and formal guidelines on the use of rFVIIa in trauma have been published in the past few years. While the authors adequately reference the "key" paper by Ken Boffard in J Trauma 2005 on two prospective randomized studies on rFVIIa in blunt and penetrating trauma patients (reference #8), they fail to cite some recent publications which provide level 1 evidence on the topic, for example:
- Rizoli SB, et al., "Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials", Crit. Care 2006, 10:R178.
- Vincent JL, et al. "Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding - a European perspective", Crit. Care 2006, 10:R120.
- Kluger Y et al., "Safety of rFVIIa in hemodynamically unstable polytrauma patients with traumatic brain injury: post hoc analysis of 30 patients from a prospective, randomized, placebo-controlled, double-blind clinical trial", Crit. Care 2007, 11:R85.
- Spahn DR et al., "Management of bleeding following major trauma: a European guideline", Crit. Care 2007, 11:R17.
- Squizzato A, Ageno W, "Recombinant activated factor VII as a general haemostatic agent: evidence-based efficacy and safety", Curr. Drug Saf. 2007, 2:155-61.
- Moltzan CJ et al., "The evidence for the use of recombinant factor VIIa in massive bleeding: development of a transfusion policy framework", Transfus. Med. 2008, 18:112-20.
In the current times of fast open-access publishing with short peer-review and turn-over times until publication, the onus remains on the author to provide scientifically accurate information. This is a sign of respect to the reader, who should be able to trust the scientific content of the growing number of peer-reviewed publications in biomedical journals.
Role of rFVIIa in hemorrhage control
2 December 2008
I read with high interest the case report by Konstantinos Vlachos and colleagues entitled "Successful use of recombinant factor VII for postoperative associated hemorrhage" (Cases Journal 2008, 1:361).
The authors have to be congratulated for their excellent management of a coagulopathic patient with massive postoperative bleeding secondary to a renal biopsy.
However, I was disappointed regarding the adequacy of the work-up of the pertinent, peer-reviewed literature in the field. The authors state that "published clinical experiences for the use of rFVIIa in trauma are limited to small series and case reports" (abstract) and "data supporting the use of rFVIIa within trauma have been limited to case series and anecdotal reports" (conclusion).
These statements are inaccurate and highly misleading.
Multiple prospective studies, including double-blind randomized trials, as well as meta-analyses, systematic reviews and formal guidelines on the use of rFVIIa in trauma have been published in the past few years. While the authors adequately reference the "key" paper by Ken Boffard in J Trauma 2005 on two prospective randomized studies on rFVIIa in blunt and penetrating trauma patients (reference #8), they fail to cite some recent publications which provide level 1 evidence on the topic, for example:
- Rizoli SB, et al., "Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials", Crit. Care 2006, 10:R178.
- Vincent JL, et al. "Recommendations on the use of recombinant activated factor VII as an adjunctive treatment for massive bleeding - a European perspective", Crit. Care 2006, 10:R120.
- Kluger Y et al., "Safety of rFVIIa in hemodynamically unstable polytrauma patients with traumatic brain injury: post hoc analysis of 30 patients from a prospective, randomized, placebo-controlled, double-blind clinical trial", Crit. Care 2007, 11:R85.
- Spahn DR et al., "Management of bleeding following major trauma: a European guideline", Crit. Care 2007, 11:R17.
- Squizzato A, Ageno W, "Recombinant activated factor VII as a general haemostatic agent: evidence-based efficacy and safety", Curr. Drug Saf. 2007, 2:155-61.
- Moltzan CJ et al., "The evidence for the use of recombinant factor VIIa in massive bleeding: development of a transfusion policy framework", Transfus. Med. 2008, 18:112-20.
In the current times of fast open-access publishing with short peer-review and turn-over times until publication, the onus remains on the author to provide scientifically accurate information. This is a sign of respect to the reader, who should be able to trust the scientific content of the growing number of peer-reviewed publications in biomedical journals.
Philip F. Stahel, MD
Attending Surgeon
Denver Health Medical Center
Competing interests
I declare that I have no competing interests.