Table 21Indirect outcomes in comparative studies of rFVIIa use in intracranial hemorrhage

ArticleStudy Design/rFVIIa userFVIIa dose (ug/kg) (SD) [Range]Sample sizeMean age (SD) [Range]Relative hematoma expansion, % [95 percent CI], (SD)Absolute hematoma expansion, mL [95 percent CI], (SD)
rFVIIaUCrFVIIaUCrFVIIaUCSigrFVIIaUCSig
Mayer 2005a23RCT Treatment40
80
160
108
92
103
9667 (12)
65 (12)
64 (13)
68 (12)16 [4–28]*
14 [2–27]*
11 [0–23]*
29 [16–44]*p=.07
p=.05
p=.02^
All Pts: p=.01^
5.4 [1.7–9.0]*
4.2 [0.3–8.0]*
2.9 [−0.8–6.6]*
8.7 [4.9–12.4]*p=.13
p=.14
p=.008^
All Pts: p=.01^
Mayer 2005b86RCT Treatment10
20
40
80
120
160
6
6
6
6
6
6
1151 (9)
68 (22)
68 (16)
58 (11)
64 (14)
53 (12)
66 (14)“same”“same”Not significantNRNRNR
Mayer 200687RCT Treatment5
20
40
80
8
8
8
8
872 (10)
60 (15)
64 (13)
62 (12)
67 (13)64 (106)
79 (172)
37 (51)
4 (9)
11 (18)Not significant13 (19)
10 (21)
1 (2)
1 (2)
2 (4)Not significant
Mayer 200888RCT Treatment20
80
276
297
26865 (14)
65 (13)
65
(14)
18 [13–24]
11 [6–17]
26 [20–32]p=.09
p=<.001
4.9 [2.9–7.0]
3.7 [1.7–5.7]
7.5 [5.4–9.6]p=.08
p=.009
Ilyas 200889Retrospective comparative
Treatment
[10–100]243076.5 (11)76.4 (12.4)NRNRNRNRNRNR
Pickard 200090Prospective comparative
Treatment
80; 80+3.5/h CI; 80+7.0/h CI55NRNRNRNRNRNRNRNR
Brody 200591Retrospective comparative
Treatment
4.8& (2.1)121571 (13)77 (7)NRNRNRNRNRNR
Hallevi 200892Retrospective comparative
Treatment
40;804614860 [38–87]58 [40– 80]11.6 (14.6)NRNR1.09 (1.37)NRNR

These studies did not meet inclusion criteria for detailed review in the comparative effectiveness analyses due to being poor quality (Table 14), but are included in the qualitative sensitivity discussions for this indication (in the section above, “Consideration of poor quality comparative observational studies”) and in the overall harms analyses near the end of this report;

.Sig=tests of statistical significance between the usual care and rFVIIa group(s). The p-values presented are those reported by the individual studies.

*

In Mayer 2005a,23 98.3 percent confidence interval is used;

^

The comparison was statistically significant according to the prespecified Bonferroni-corrected threshold of p=0.0167 in Mayer 2005a23;

&

Mean dose in mg rather than ug/kg of body weight;

UC=usual care; CI=continuous infusion; NR=not reported

These studies did not meet inclusion criteria for detailed review in the comparative effectiveness analyses due to being poor quality (Table 14), but are included in the qualitative sensitivity discussions for this indication (in the section above, “Consideration of poor quality comparative observational studies”) and in the overall harms analyses near the end of this report;

In Mayer 2005a,23 98.3 percent confidence interval is used;

The comparison was statistically significant according to the prespecified Bonferroni-corrected threshold of p=0.0167 in Mayer 2005a23;

Mean dose in mg rather than ug/kg of body weight;

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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