Abstract
OBJECTIVE: The aim of this study was to assess safety and effectiveness of recombinant activated factor VII (rFVIIa) in patients with refractory bleeding undergoing acute aortic dissection surgery with deep hypothermic circulatory arrest. DESIGN: Propensity score-matched analysis. SETTING: University hospital. PATIENTS: Twenty-three cardiac surgery patients receiving rFVIIa compared with 23 matched controls. INTERVENTIONS: An intravenous bolus of rFVIIa (70 μg/kg) was administered at the end of a complete transfusion protocol. Five patients received rFVIIa in the operating room, and 18 patients received rFVIIa in the intensive care unit. Four of the intensive care unit patients required a second dose. MEASUREMENTS AND MAIN RESULTS: Blood loss and transfusion requirements were significantly reduced in the period after rFVIIa administration. A highly significant reduction in hourly blood loss was found at -1 hr vs. 0 hrs and 0 hrs vs. 1 hr (-194 and -77.5 mL, respectively; both adjusted p <.001). In addition, significant improvements of international normalized ratio (p <.001), partial thromboplastin time (p <.001), platelet count (p <.001), fibrinogen (p <.001), and antithrombin (p <.001) were detected after rFVIIa administration. The two groups did not differ regarding adverse events. CONCLUSIONS: rFVIIa was successfully used as an additional therapy both during and after acute aortic dissection surgery with deep hypothermic circulatory arrest, when bleeding was refractory to conventional methods. Randomized studies are necessary to confirm the safety and efficacy of rFVIIa in this setting.
| Original language | English |
|---|---|
| Pages (from-to) | 1685-1690 |
| Number of pages | 6 |
| Journal | Critical Care Medicine |
| Volume | 35 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - Jul 2007 |
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Keywords
- Bleeding
- Cardiac surgery
- Hemostasis
- Recombinant activated factor VII
- Thromboembolism
- Transfusion
ASJC Scopus subject areas
- Critical Care and Intensive Care Medicine
Cite this
Recombinant activated factor VII for refractory bleeding after acute aortic dissection surgery : A propensity score analysis. / Tritapepe, Luigi; De Santis, Vincenzo; Vitale, Domenico; Nencini, Cecilia; Pellegrini, Fabio; Landoni, Giovanni; Toscano, Federico; Miraldi, Fabio; Pietropaoli, Paolo.
In: Critical Care Medicine, Vol. 35, No. 7, 07.2007, p. 1685-1690.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Recombinant activated factor VII for refractory bleeding after acute aortic dissection surgery
T2 - A propensity score analysis
AU - Tritapepe, Luigi
AU - De Santis, Vincenzo
AU - Vitale, Domenico
AU - Nencini, Cecilia
AU - Pellegrini, Fabio
AU - Landoni, Giovanni
AU - Toscano, Federico
AU - Miraldi, Fabio
AU - Pietropaoli, Paolo
PY - 2007/7
Y1 - 2007/7
N2 - OBJECTIVE: The aim of this study was to assess safety and effectiveness of recombinant activated factor VII (rFVIIa) in patients with refractory bleeding undergoing acute aortic dissection surgery with deep hypothermic circulatory arrest. DESIGN: Propensity score-matched analysis. SETTING: University hospital. PATIENTS: Twenty-three cardiac surgery patients receiving rFVIIa compared with 23 matched controls. INTERVENTIONS: An intravenous bolus of rFVIIa (70 μg/kg) was administered at the end of a complete transfusion protocol. Five patients received rFVIIa in the operating room, and 18 patients received rFVIIa in the intensive care unit. Four of the intensive care unit patients required a second dose. MEASUREMENTS AND MAIN RESULTS: Blood loss and transfusion requirements were significantly reduced in the period after rFVIIa administration. A highly significant reduction in hourly blood loss was found at -1 hr vs. 0 hrs and 0 hrs vs. 1 hr (-194 and -77.5 mL, respectively; both adjusted p <.001). In addition, significant improvements of international normalized ratio (p <.001), partial thromboplastin time (p <.001), platelet count (p <.001), fibrinogen (p <.001), and antithrombin (p <.001) were detected after rFVIIa administration. The two groups did not differ regarding adverse events. CONCLUSIONS: rFVIIa was successfully used as an additional therapy both during and after acute aortic dissection surgery with deep hypothermic circulatory arrest, when bleeding was refractory to conventional methods. Randomized studies are necessary to confirm the safety and efficacy of rFVIIa in this setting.
AB - OBJECTIVE: The aim of this study was to assess safety and effectiveness of recombinant activated factor VII (rFVIIa) in patients with refractory bleeding undergoing acute aortic dissection surgery with deep hypothermic circulatory arrest. DESIGN: Propensity score-matched analysis. SETTING: University hospital. PATIENTS: Twenty-three cardiac surgery patients receiving rFVIIa compared with 23 matched controls. INTERVENTIONS: An intravenous bolus of rFVIIa (70 μg/kg) was administered at the end of a complete transfusion protocol. Five patients received rFVIIa in the operating room, and 18 patients received rFVIIa in the intensive care unit. Four of the intensive care unit patients required a second dose. MEASUREMENTS AND MAIN RESULTS: Blood loss and transfusion requirements were significantly reduced in the period after rFVIIa administration. A highly significant reduction in hourly blood loss was found at -1 hr vs. 0 hrs and 0 hrs vs. 1 hr (-194 and -77.5 mL, respectively; both adjusted p <.001). In addition, significant improvements of international normalized ratio (p <.001), partial thromboplastin time (p <.001), platelet count (p <.001), fibrinogen (p <.001), and antithrombin (p <.001) were detected after rFVIIa administration. The two groups did not differ regarding adverse events. CONCLUSIONS: rFVIIa was successfully used as an additional therapy both during and after acute aortic dissection surgery with deep hypothermic circulatory arrest, when bleeding was refractory to conventional methods. Randomized studies are necessary to confirm the safety and efficacy of rFVIIa in this setting.
KW - Bleeding
KW - Cardiac surgery
KW - Hemostasis
KW - Recombinant activated factor VII
KW - Thromboembolism
KW - Transfusion
UR - http://www.scopus.com/inward/record.url?scp=34250901460&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34250901460&partnerID=8YFLogxK
U2 - 10.1097/01.CCM.0000269033.89428.B3
DO - 10.1097/01.CCM.0000269033.89428.B3
M3 - Article
C2 - 17522585
AN - SCOPUS:34250901460
VL - 35
SP - 1685
EP - 1690
JO - Critical Care Medicine
JF - Critical Care Medicine
SN - 0090-3493
IS - 7
ER -