Abstract
To describe the development of a pharmacy driven off-label recombinant factor seven (rFVIIa) protocol by a multi-disciplinary team for critical bleeding. A multi-disciplinary team made up of members from several critical care and surgical departments within the hospital were formed and charged with developing a standardized approach to how rFVIIa would be used for critical bleeding in an academic medical center. Groups represented on the multi-disciplinary team included clinical pharmacy, emergency medicine, pulmonary, hematology, cardiothoracic surgery, trauma, neurosurgery, and vascular surgery physicians. A pharmacist driven off-label rFVIIa protocol was developed and implemented for the use in those patients with critical bleeding. The protocol was based on the available literature and local expert opinion. Through the use of this protocol a significantly smaller average dose of rFVIIa is now being used when compared to those patients treated prior to the new protocol (47.5 vs. 62.2 mcg/kg, p = 0.036) while all-cause mortality was not significantly altered (35 vs. 48.8 %, p = 0.057). An effective and safe pharmacy driven protocol was implemented by a multi-disciplinary team for rFVIIa as seen by providing a significantly lower average dose of rFVIIa while not sacrificing for overall patient mortality.
Similar content being viewed by others
References
Shander A (2007) Financial and clinical outcomes associated with surgical bleeding complications. Surgery 142(4 Suppl):S20–S25
Rady M, Ryan T, Starr N (1998) Perioperative determinants of morbidity and mortality in elderly patients undergoing cardiac surgery. Crit Care Med 26(2):225–235
Marietta M, Facchini L, Pedrazzi P, Busani S, Torelli G (2006) Pathophysiology of bleeding in surgery. Transplant Proc 38(3):812–814
Wąsowicz M, Meineri M, McCluskey SM, Mitsakakis N, Karkouti K (2009) The utility of thromboelastography for guiding recombinant activated factor VII therapy for refractory hemorrhage after cardiac surgery. J Cardiothorac Vasc Anesth 23(6):828–834
Spahn D, Cerny V, Coats T et al (2007) Management of bleeding following major trauma: a European guideline. Crit Care 11(1):R17
Koh M, Hunt BJ (2003) The management of perioperative bleeding. Blood Rev 17(3):179–185
Hedner U, Erhardtsen E (2002) Potential role for rFVIIa in transfusion medicine. Transfusions 42(1):114–124
Hoffman M (2001) III, DMM: a cell-based model of hemostasis. Thromb Haemost 85:958–968
Hedner U, Erhardtsen E (2000) Recombinant coagulation factor VIIa: from the concept to clinical application in hemophilia treatment in 2000. Semin Thromb Hemost 26:363–369
Friederich P, Geerdink M, Spataro M (2000) The effect of the administration of recombinant activated factor VII (NovoSeven) on perioperative blood loss in patients under undergoing transabdominal retropubic prostatectomy: the PROSE study. Blood Coagul Fibrinolysis 11(Suppl 1):S129–S132
Levi M, Peters M, Buller H (2005) Efficacy and safety of recombinant factor VIIa for treatment of severe bleeding: a systematic review. Crit Care Med 33:883–890
Macik BG, Lindley CM, Lusher J et al (1993) Safety and initial clinical efficacy of three dose levels of recombinant activated factor VII (rFVIIa): results of a phase I study. Blood Coagul Fibrinolysis 4(4):521–528
Shander A, Goodnough L, Ratko T (2005) Consensus recommendations for the off-label use of recombinant human factor VIIa (NovoSeven) therapy. P and T 30:644–658
Goodnough L, Lublin D, Zhang L (2007) Transfusion medicine service policies for recombinant factor VIIa administration. Transfusion 44:1325–1331
Warren O, Mandal K, Hadjianastassiou V (2007) Recombinant activated factor VII in cardiac surgery: a systematic review. Ann Thorac Surg 83:707–714
O’Connell K, Wood J, Wise R, Lozier J, Braun M (2006) Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA 295:293–298
Levi M, Levy JH, Andersen HF, Truloff D (2010) Safety of recombinant activated factor VII in randomized clinical trials. N Engl J Med 363(19):1791–1800
Martinoqitz U, Kenet G, Segal E, Luboshitz J, Lubetsky A et al (2001) Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma 51:431–439
Smith K, Hecht K, Armistead A, Davis G (2003) Evolution and operation of a pharmacy residency on-call program. Am J Health Syst Pharm 60:2236–2241
Mcconeghy KW, Winstead PS, Cook AM, Martin CA, Weant KA, Flynn JD (2012) Benefits of a 24-h inhouse on-call program for pharmacy residents. Am J Health Syst Pharm 69(24):2160–2164
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Bain, J., Lewis, D., Bernard, A. et al. Implementation of an off-label recombinant factor VIIa protocol for patients with critical bleeding at an academic medical center. J Thromb Thrombolysis 38, 447–452 (2014). https://doi.org/10.1007/s11239-014-1107-0
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11239-014-1107-0