Table 11General characteristics of all included studies by clinical indication

ArticleStudy designTime periodCountry or RegionSettingSample size#Mean age*, years (SD) [Range]rFVIIa dose, μg/kgManufacturer Sponsorship
Intracranial hemorrhage
Mayer 2005a23RCT8/2002–3/2004Australia, Europe, Asia, North America73 centers303 (3 arms)9664 – 6768 (12)40; 80; 160Funding
Mayer 2005b86RCT8/2001–10/2002Australia, Europe, Asia14 centers36 (6 arms)1151 – 6866 (14)10; 20; 40; 80; 120; 160Funding
Mayer 200687RCT11/2001–3/2003USA17 centers32 (4 arms)860 – 7267 (13)5; 20; 40; 80Funding
Mayer 200888RCT5/2005–2/2007Australia, Europe, Asia, North America122 centers573 (2 arms)26865 (14)65 (14)20; 80Funding
Ilyas 200889Retrospective comparative1/2000–NRUSA1 university hospital243076.5 (11)76.4 (12.4)10–100NR
Pickard 200090Prospective comparativeNRNRMulticenter55NRNR80; 80+3.5CI; 7.0 CIAffiliation
Brody 200591Retrospective comparative3/2002–1/2003USA1 university hospital121571 (13)77 (7)Mean: 4.8 mg
SD: 2.1 mg
Hallevi 200892Retrospective comparativeNRUSA1 university hospital4614860 [38–87]58 [40–80]40; 80Affiliation
Sutherland 200893Retrospective non-comparative3/2005–12/2006Canada2 centers15-68U [25–81]-Median: 60
Range: 25–81
Herbertson 200894 (also reports on body trauma)Retrospective non-comparative6/2001–12/2003InternationalOnline registry20-7.7 (5.8)-Median: 100
Range: 9–393
Nussbaum 200995Retrospective non-comparativeNRUSA1 center18-56.8 [42–85]-Range: 40–160NR
Body trauma
Boffard 200596Two RCTs3/2002–9/2003Australia, Canada, Europe, Israel, South Africa32 centers139 (2 arms)138 (2 arms)29 – 3332 – 35200 followed by two 100Funding
Rizoli 200697Retrospective comparative1/2000–1/2005Canada1 university center382043741NRAffiliation
Spinella 200898Retrospective comparative12/2003–10/2005IraqCombat support hospitals4975NRNR120NR
Fox 200999Retrospective comparative4/2006–8/2007IraqCombat support hospitals411228 (9)24 (10)90–120None
Dutton 2004100Retrospective comparative6/2001–12/2003USA1 university hospital8132–449^41(21)NR50; 100Affiliation
Harrison 2005101Retrospective comparative2/2003–12/2003USA1 hospital297241 (21)42 (22)Mean: 60NR
Cameron 2007102Retrospective non-comparative1/2001–9/2006Australia, New Zealand53 centers108-38U [11–91]-Median: 90
IQR: 78–105
Felfernig 2007103Retrospective non-comparative9/2000–8/2003Europe and AustraliaHaemostasi s database45-31 [5–81]-Mean: 74
SD: 27
Martinowitz 2005104Retrospective non-comparativeNRIsraelTrauma registry36-19.5 [14–65]-Median: 140
Range: 70–540
Alten 2009105Retrospective non-comparative1999–2006USA1 university center15-7 [IQR 1.1–14]-Median: 88
Range: 27–160
Brain trauma
Narayan 2008106RCT8/2004–5/2006Canada, Europe, Asia38 centers613652 (22)51 (20)40; 80; 120; 160; 200Funding
Stein 2008107Retrospective comparative7/2002–6/2006USA1 university center293440 (25)38 (20)Range: 8 –140Affiliation
Tawil 2008108Retrospective comparative1/2004–12/2005USA1 university center31353NRNRNRNR
Bartal 2007109Prospective non- comparativeNRNR1 center15-61 (11)-Mean: 59
Range: 40–90
Liver transplantation
Lodge 2005110RCT8/2001–9/2003Australia, Europe, North America14 centers121 (2 arms)6153 (10)52 (12)60; 120Affiliation
Planinsic 2005111RCT2/2000–9/2000Europe, USA9 centers64 (3 arms)1949 – 5250 (11)20; 40; 80Affiliation
Pugliese 2007112RCT11/2003–7/2004Italy1 university center1010NRNR40NR
Liu 2009113RCT3/2003–7/2006China1 university center141451.9 [36–54]47.5 [41–65]70–80NR
Hendriks 2001114Prospective comparative12/1998–9/1999Netherlands1 center6643U [37–61]48U [34–63]80Affiliation
De Gasperi 2005115Retrospective comparative2/2003Italy1 center6645 (4)47 (9)20; 40NR
Kalicinski 2005116Retrospective comparativeNRPoland1 center286113 (4)11 (6)Mean: 52 Range: 30–100NR
Niemann 2006117Retrospective comparative2000–2004USA1 university center111148 (15)41 (17)Mean: 58 SD: 18NR
Adult cardiac surgery
Diprose 2005118RCTNRUK1 center101070U [64–77]I63U [59–66]I90Funding
Gill 2009119RCT8/2004–11/200713 countries30 centers1046863–6862 (16)40; 80Funding
Karkouti 2005120Retrospective comparative11/2002–2/2004Canada1 center51515659Mean: 60 SD: 13None
Gelsomino 2008121Retrospective comparative9/2005–6/2007Italy1 center404070 (9)76 (10)Median: 19 IQR: 6–16NR
Tritapepe 2007122Retrospective comparative1/2003–12/2005Italy1 center232362 (9)62 (9)Mean: 82NR
von Heymann 2005123Retrospective comparative6/2000–3/2003NR1 center2424656560–80 with possible repeat dosesNR
Bowman 2008124Retrospective comparative1/2001–12/2006USA1 center3638558 (15)NRMean: 100NR
Trowbridge 2009125Prospective comparativeNRUSA1 center1718770 (9)67 (11)NRNone
Filsoufi 2006126Retrospective non-comparative6/2003–12/2005USA1 center17-63 (15)-Mean: 103 SD: 30NR
Gandhi 2007127Retrospective non-comparative1/2003–8/2005USA1 center17-53[38–64]-Mean: 78 Range: 24–189NR
Hyllner 2005128Retrospective non-comparative1/2004–8/2004Sweden1 center24-60U[34–82]-Mean: 72NR
McCall 2006129Retrospective non-comparative12/2002–8/2005Australia1 center53-68[55–75]I-Mean: 90 SD: 15Affiliation
Raivio 2005130Retrospective non-comparative6/2002–10/2004Finland1 center16-60 (15)-Mean: 65 Range: 24–192NR
Aggarwal 2004131Retrospective non-comparative6/2001–6/2003USA1 center24-65U[26–85]-90NR
Karkouti 2008132Retrospective non-comparative1/2003–12/2006Canada18 centers503-62 (15)-Median: 62 IQR: 40–89Funding
Dunkley 2008133Retrospective non-comparative1/2001–9/2006Australia, New Zealand21 centers293-63 (15)-Median: 92 IQR: 82–103Funding
Bruckner 2009134 (2 doses)Retrospective non-comparative1/2004–11/2006USA1 center32
51 (17)
51 (17)
Range: 10–20
Range: 30–70
Masud 2009135Retrospective non-comparative1/2004–9/2005USA1 university hospital93-60.6 (14.5)-Mean: 56.2 SD: 26.5Affiliation
Hsia 2009136Retrospective non-comparative1/2003–6/2007United Kingdom1 center23-55 [18–84]-NRNR
Pediatric cardiac surgery
Ekert 2006137RCTNRAustralia1 center40354 months4 monthsMean: 63NR
Agarwal 2007138Retrospective comparative1/2000–12/2004USA1 center242210 days [4–3285]7 days [2–240]Mean: 43 SD: 23None
Tobias 2004139Prospective comparative1/2003Dominican Republic1 center989 (4)10 (3)90Affiliation
Niles 2008140Retrospective comparative2004–2006USA1 center151560 days (99); 5293 days (471)**16 days (19); 4531 days (2758)**Range: 76–282; 26–956**None
Friederich 2003141RCTNRNetherlands1 center24 (2 arms)1261 – 6463 (8)20; 40Affiliation
Other liver disease
Jeffers 2002142Non-comparative RCT#NRUSA3 centers71 (5 arms)-46 – 52-5; 20; 80; 120Affiliation
Bosch 2004143RCT4/2001–4/2002Europe26 centers12112154 (11)53 (12)800Funding
Shao 2006144RCT7/2001–12/2002China, Taiwan, Thailand7 centers155(2 arms)7653 – 5449U [30–75]50; 100Affiliation
Bosch 2008145RCT4/2004–8/200612 countries in Europe and Asia31 centers170 (2 arms)8655 (12)54 (10)300; 600Funding
Shami 2003146Retrospective comparative12/1999-NRUSA1 center7834 [16–64]28 [7–45]40; 80NR
Ahonen 2007147Retrospective comparativeNRFinland1 center262233 (4)35 (4)Mean: 100 SD: 14NR
Hossain 2007148Retrospective comparative3/2005–10/2006Pakistan1 center181629U [26–32]I29U [26–30]I70NR
McMorrow 2008149Retrospective comparative2003–2006Ireland1 center6634 (3)31 (5)NRNR
Chuansumrit 2005150RCT7/2001–12/2002Thailand, Philippines5 centers1699 (4)11 (3)100; 200Funding
Pihusch 2005151RCT4/2001–10/2003Australia, Europe21 centers77 (3 arms)2336 – 3839U [18–64]280; 560; 1120Funding
Gupta 2007152Retrospective comparative1/2002–12/2004USA1 center2463NRNRNRNone
Other surgery
Lodge 2005153RCT1/2001–1/2002France, Spain, Germany, UK13 centers122 (2 arms)6356 (13)56 (14)20; 80Funding
Raobaikady 2005154RCT8/2002–3/2004UK1 center242444U [18–57]38U [18–57]90; 180Funding
Johansson 2007155RCT6/2001–12/2003Denmark1 center9954U [22–85]38U [19–81]80Funding
Sachs 2007156RCT7/2004–2/2006USA13 centers36 (3 arms)1345 – 4650 [17–65]90; 180; 360Funding
Roitberg 2005157Retrospective comparative7/2001–11/2002USA1 center29246067NRNR
Kolban 2006158Retrospective comparative2000–2003Poland1 center262617 [10–22]16 [12–19]Mean: 23NR

For Key Question 2–4 indications, these studies did not meet inclusion criteria for the comparative effectiveness analyses due to poor quality (Table 14) (so are included in qualitative sensitivity discussions within their respective indication and for the harms analyses) or because they were non-comparative studies (so are included only in the harms analyses).


For RCTs with more than one dosing arm, the range of mean ages of each dosing arm is presented.


Patients were divided into 2 groups: those <30 kg (N=11) and those>30 kg (N=4), respectively;


The sample size presented is the largest sample size the study reported for each treatment arm. Sample size may vary for each outcome reported within a study.


Dutton 2004100 has multiple control groups. The range of sample sizes is presented.


Jeffers 2002142 did not have a usual care (i.e. placebo) group, but randomized patients in a double-blind fashion to doses of 5, 20, 80, and 120 ug/kg rFVIIa.





UC=usual care; NR=not reported; IQR=interquartile range;

Funding=Novo Nordisk funded the study or an author or statistician was an employee of Novo Nordisk; Affiliation=an author belonged to the Novo Nordisk speakers bureau, or received fees, payments, or funding for other projects or work from Novo Nordisk.

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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