Pharmacokinetics of recombinant activated factor VII in trauma patients with severe bleeding

Klitgaard, Thomas; Palacios, Rene Tabanera y; Boffard, Kenneth D.; Iau, Philip; Warren, Brian; Rizoli, Sandro; Rossaint, Rolf; Kluger, Yoram; Riou, Bruno

doi:10.1186/cc4977

Cited by 33 publications

(6 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Whereas the dosing administered in the published RCTs in trauma patients was recommended by a group of European experts [ 654 ], Israeli guidelines based on findings from a case series of 36 patients who received rFVIIa on a compassionate-use basis [ 641 ] proposed an initial dose of 120 μg/kg (between 100 and 140 μg/kg) and (if required) a second and third dose. Pharmacokinetic modelling techniques have shown that the dose regimen for rFVIIa treatment used in the RCT described above is capable of providing adequate plasma levels of drug to support haemostasis [ 655 ]. Bain et al compared their institutional rFVIIa low-dose protocol to previous practice using higher doses of rFVIIa.…”

Section: Resultsmentioning

confidence: 99%

The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition

et al. 2016

Self Cite

View full text Add to dashboard Cite

BackgroundSevere trauma continues to represent a global public health issue and mortality and morbidity in trauma patients remains substantial. A number of initiatives have aimed to provide guidance on the management of trauma patients. This document focuses on the management of major bleeding and coagulopathy following trauma and encourages adaptation of the guiding principles to each local situation and implementation within each institution.MethodsThe pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004 and included representatives of six relevant European professional societies. The group used a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were reconsidered and revised based on new scientific evidence and observed shifts in clinical practice; new recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated. This guideline represents the fourth edition of a document first published in 2007 and updated in 2010 and 2013.ResultsThe guideline now recommends that patients be transferred directly to an appropriate trauma treatment centre and encourages use of a restricted volume replacement strategy during initial resuscitation. Best-practice use of blood products during further resuscitation continues to evolve and should be guided by a goal-directed strategy. The identification and management of patients pre-treated with anticoagulant agents continues to pose a real challenge, despite accumulating experience and awareness. The present guideline should be viewed as an educational aid to improve and standardise the care of the bleeding trauma patients across Europe and beyond. This document may also serve as a basis for local implementation. Furthermore, local quality and safety management systems need to be established to specifically assess key measures of bleeding control and outcome.ConclusionsA multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. The implementation of locally adapted treatment algorithms should strive to achieve measureable improvements in patient outcome.Electronic supplementary materialThe online version of this article (doi:10.1186/s13054-016-1265-x) contains supplementary material, which is available to authorized users.

show abstract

Section: Resultsmentioning

confidence: 99%

The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition

et al. 2016

Self Cite

View full text Add to dashboard Cite

show abstract

“…Whereas the dosing used in the published RCTs in trauma patients is also recommended by a group of European experts [ 514 ], Israeli guidelines based on findings from a case series of 36 patients who received rFVIIa on a compassionate-use basis [ 504 ] propose an initial dose of 120 µg/kg (between 100 and 140 µg/kg) and (if required) a second and third dose. Pharmacokinetic modelling techniques have shown that the dose regimen for rFVIIa treatment used in the RCT described above is capable of providing adequate plasma levels of drug to support haemostasis [ 515 ].…”

Section: Resultsmentioning

confidence: 99%

Management of bleeding and coagulopathy following major trauma: an updated European guideline

Bouillon²,

et al. 2013

Self Cite

View full text Add to dashboard Cite

IntroductionEvidence-based recommendations are needed to guide the acute management of the bleeding trauma patient. When these recommendations are implemented patient outcomes may be improved.MethodsThe multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing a guideline for the management of bleeding following severe injury. This document represents an updated version of the guideline published by the group in 2007 and updated in 2010. Recommendations were formulated using a nominal group process, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence and based on a systematic review of published literature.ResultsKey changes encompassed in this version of the guideline include new recommendations on the appropriate use of vasopressors and inotropic agents, and reflect an awareness of the growing number of patients in the population at large treated with antiplatelet agents and/or oral anticoagulants. The current guideline also includes recommendations and a discussion of thromboprophylactic strategies for all patients following traumatic injury. The most significant addition is a new section that discusses the need for every institution to develop, implement and adhere to an evidence-based clinical protocol to manage traumatically injured patients. The remaining recommendations have been re-evaluated and graded based on literature published since the last edition of the guideline. Consideration was also given to changes in clinical practice that have taken place during this time period as a result of both new evidence and changes in the general availability of relevant agents and technologies.ConclusionsA comprehensive, multidisciplinary approach to trauma care and mechanisms with which to ensure that established protocols are consistently implemented will ensure a uniform and high standard of care across Europe and beyond.Please see related letter by Morel et alhttp://ccforum.com/content/17/4/442

show abstract

“…Whereas the above dosing recommendation is based on the only published RCT available in trauma patients and is also recommended by a group of European experts [ 317 ], Israeli guidelines based on findings from a case series of 36 patients who received rFVIIa on a compassionate-use basis in Israel [ 313 ] propose an initial dose of 120 μg/kg (between 100 and 140 μg/kg) and (if required) a second and third dose. Pharmacokinetic modelling techniques have shown that the dose regimen for rFVIIa treatment used in the above cited RCT is capable of providing adequate plasma levels of drug to support haemostasis [ 318 ].…”

Section: Resultsmentioning

confidence: 99%

Management of bleeding following major trauma: an updated European guideline

et al. 2010

Self Cite

View full text Add to dashboard Cite

IntroductionEvidence-based recommendations are needed to guide the acute management of the bleeding trauma patient, which when implemented may improve patient outcomes.MethodsThe multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing a guideline for the management of bleeding following severe injury. This document presents an updated version of the guideline published by the group in 2007. Recommendations were formulated using a nominal group process, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence and based on a systematic review of published literature.ResultsKey changes encompassed in this version of the guideline include new recommendations on coagulation support and monitoring and the appropriate use of local haemostatic measures, tourniquets, calcium and desmopressin in the bleeding trauma patient. The remaining recommendations have been reevaluated and graded based on literature published since the last edition of the guideline. Consideration was also given to changes in clinical practice that have taken place during this time period as a result of both new evidence and changes in the general availability of relevant agents and technologies.ConclusionsThis guideline provides an evidence-based multidisciplinary approach to the management of critically injured bleeding trauma patients.

show abstract

Pharmacokinetics of recombinant activated factor VII in trauma patients with severe bleeding

Abstract: Introduction Recombinant activated factor VII (rFVIIa) has been used as adjunctive therapy in trauma patients with severe bleeding. However, its pharmacokinetics profile remains unknown.

Cited by 33 publications

References 27 publications

The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition

The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition

Management of bleeding and coagulopathy following major trauma: an updated European guideline

Management of bleeding following major trauma: an updated European guideline

Contact Info

Product

Resources

About