title: Economic and outcomes consequences of TachoSil®: a systematic review.
abstract: BACKGROUND
  TachoSil(®) is a medicated sponge coated with human fibrinogen and human thrombin. It is indicated as a support treatment in adult surgery to improve hemostasis, promote tissue sealing, and support sutures when standard surgical techniques are insufficient. This review systematically analyses the international scientific literature relating to the use of TachoSil in hemostasis and as a surgical sealant, from the point of view of its economic impact.
  
  
  METHODS
  We carried out a systematic review of the PubMed literature up to November 2013. Based on the selection criteria, papers were grouped according to the following outcomes: reduction of time to hemostasis; decrease in length of hospital stay; and decrease in postoperative complications.
  
  
  RESULTS
  Twenty-four scientific papers were screened, 13 (54%) of which were randomized controlled trials and included a total of 2,116 patients, 1,055 of whom were treated with TachoSil. In the clinical studies carried out in patients undergoing hepatic, cardiac, or renal surgery, the time to hemostasis obtained with TachoSil was lower (1-4 minutes) than the time measured with other techniques and hemostatic drugs, with statistically significant differences. Moreover, in 13 of 15 studies, TachoSil showed a statistically significant reduction in postoperative complications in comparison with the standard surgical procedure. The range of the observed decrease in the length of hospital stay for TachoSil patients was 2.01-3.58 days versus standard techniques, with a statistically significant difference in favor of TachoSil in eight of 15 studies.
  
  
  CONCLUSIONS
  This analysis shows that TachoSil has a role as a supportive treatment in surgery to improve hemostasis and promote tissue sealing when standard techniques are insufficient, with a consequent decrease in postoperative complications and hospital costs.
authors.affiliation: Department of Drug Sciences, University of Pavia, Pavia, Italy ; Studi Analisi Valutazioni Economiche (SAVE), Milan, Italy.
authors.forename: Giorgio L
authors.initials: GL
authors.lastname: Colombo
authors.affiliation: Hospital Pharmacy, Spedali Civili Brescia, Brescia, Italy.
authors.forename: Daria
authors.initials: D
authors.lastname: Bettoni
authors.affiliation: Studi Analisi Valutazioni Economiche (SAVE), Milan, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Di Matteo
authors.affiliation: Hospital Pharmacy, Spedali Civili Brescia, Brescia, Italy.
authors.forename: Camilla
authors.initials: C
authors.lastname: Grumi
authors.affiliation: Città della Salute e della Scienza di Torino, Presidio Molinette, Turin, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Molon
authors.affiliation: Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Spinelli
authors.affiliation: Scuola di Specializzazione in Farmacia Ospedaliera, Università La Sapienza, Roma, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Mauro
authors.affiliation: Città della Salute e della Scienza di Torino, Presidio Molinette, Turin, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Tarozzo
authors.affiliation: Studi Analisi Valutazioni Economiche (SAVE), Milan, Italy.
authors.forename: Giacomo M
authors.initials: GM
authors.lastname: Bruno
mesh_terms: D016063:Blood Loss, Surgical / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D004338:Drug Combinations; D016527:Drug Costs; D005340:Fibrinogen / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000191:economics*; D006490:Hemostatics / Q000191:economics* / Q000627:therapeutic use*; D017721:Hospital Costs; D006801:Humans; D007902:Length of Stay / Q000191:economics; D010043:Outcome and Process Assessment, Health Care / Q000191:economics*; D019106:Postoperative Hemorrhage / Q000191:economics / Q000517:prevention & control; D013917:Thrombin / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D006490:Hemostatics; C518955:TachoSil; D005340:Fibrinogen; D013917:Thrombin
keywords: TachoSil®; cost analysis; economic evaluation; outcomes research; systematic review