Table 54Harms noted in the analysis of rFVIIa use

Study DesignNumber of StudiesStudy ReferencesMean Age Range (yrs)Mean rFVIIa dose (mcg/kg)Sample SizeMortalityThromboembolic Events
Intracranial hemorrhage
Premier-64.7-12350.34-
RCT4 (with 2 to 6 arms)Mayer 2005a23, Mayer 2005b86, Mayer 200888, Mayer 20068751 to 725 to 1606 to 297 per arm0 to 0.380 to 0.33
Comparative observational4Hallevi 200892, Brody 200591, Pickard 200090, Ilyas 20088960 to 77805 to 460.13 to 0.430.04 to 0.2
Non-comparative Observational3Sutherland 200893, Herbertson 200894, Nussbaum 2009958 to 6860 to 10015 to 200.13 to 0.220 to 0.44
Body trauma
Premier-52.8-21360.33-
RCT1-BluntBoffard 20059633400690.250.03
1-PenetratingBoffard 20059629400700.240.06
Comparative Observational5Rizoli 200697, Fox 200999, Dutton 2004100, Harrison 2005101, Nascimento 200818128 to 4160 to 10029 to 810.07 to 0.580.07–0.12*
Non-comparative Observational7Cameron 2007102, Felfernig 2007103, Thomas 2007228, Martinowitz 2005104, Perkins 2007182, Alten 2009105, Herbertson 2008947 to 4468 to 14015 to 2420.13 to 0.420 to 0.11
Brain trauma
Premier-63.3-12240.34-
RCT1 (with 5 arms)Narayan 200810651.540 to 20011 to 14 per arm0 to 0.330 to 0.21
Comparative observational1Stein 200810729.9-290.340.21
Non-comparative Observational1Bartal 20071096159150.070
Liver transplantation
Premier-51.8-330.38-
RCT4 (with 1 to 3 arms)Lodge 2005110, Planinsic 2005111, Pugliese 2007112, Liu 200911349 to 5320 to 41210 to 63 per arm0.02 to 0.08#0 to 0.19^
Comparative Observational4Hendriks 2001114, Kalicinski 2005116, Niemann 2006117, De Gasperi 200511513 to 4830 to 806 to 280 to 0.070 to 0.17
Adult cardiac surgery
Premier-65.3-24190.23-
RCT2 (with 1 to 2 arms)Diprose 2005,118 Gill 200911963 to 6440 to 909 to 680 to 0.110.06 to 0.22
Comparative Observational4Bowman 2008124, Gelsomino 2008121, von Heymann 2005123, Trowbridge 200812558 to 7018 to 10017 to 400.05 to 0.380 to 0.11
Non-comparative Observational13Karkouti 2006215, Tritapepe 2007122, Filsoufi 2006126, Gandhi 2007127, Hyllner 2005128, McCall 2006129, Raivio 2005130, Aggarwal 2004131, Karkouti 2008132, Dunkley 2008133, Bruckner 2009134, Masud 2009135, Hsia 200913651 to 6815 to 10316 to 5030 to 0.870 to 0.39
Pediatric cardiac surgery
Premier-2.6-2740.22-
RCT1 (with 1 arm)Ekert 20061370.36340-0
Comparative Observational3Agarwal 2007138, Tobias 2004139, Niles 20081400 to 960 to 2864 to 2400 to 0.08
Prostatectomy
Premier-68.9-150-
RCT1 (with 2 arms)Friederich 200314161 to 6420 to 408 to 1600 to 0.13
*

The rate of thromboembolic events is based on a continuation of Rizoli et al.97 with 72 patients.229

Data on mortality and thromboembolic events from Perkins et al.182 (an overlapping non-comparative study) are used instead of Spinella et al.98 (a comparative observational study analysed in the body trauma section above) because the former has a larger sample size.

#

Mortality is underestimated because 2 deaths each in Lodge et al.110 and Planinsic et al.111 were not reported by treatment arm.

^

Thromboembolic events are underestimated because only arterial thromboembolic events were counted in Planinsic et al.111

From: Results

Cover of Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care [Internet].
Comparative Effectiveness Reviews, No. 21.
Yank V, Tuohy CV, Logan AC, et al.

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