Table 36Indirect outcomes in comparative studies of rFVIIa use in liver transplantation

ArticleStudy Design/rFVIIa useMean dose (SD) [Range]Sample sizeMean age (SD) [IQR]Mean RBC transfusion (SD) [IQR]OR time, minutes (SD)ICU LOS, days (SD)
rFVIIaUCrFVIIaUsual carerFVIIaUsual careSigrFVIIaUsual careSigrFVIIaUsual careSig
Lodge 2005110RCT Prophylaxis180#

360#
62*

56*
6153.3 (11.2)

52.6 (9.2)
52.3 (11.5)7.0U [0–76.5]R
6.3U [0–76.4]R
8.2U [1.5–100.0]RNS“same”“same”NS3.5

3.0
3.0NS
Planinsic 2005111RCT Prophylaxis20

40

80
18

23

22
1949.4 (13.4)

49.7 (10.1)

51.9 (8.8)
49.9 (11.0)10.0U [3.0–18.0]
13.0U [7.0–24.0]
10.0U [3.2–21.0]
11.1U [7.0–17.0]NS“same”“same”NS“same”“same”NS
Pugliese 2007112RCT Prophylaxis401010--1.2 (0.53)2.3 (0.44)p=.02408 (56)432 (48)NS4.8 (1.3)5.2 (1.2)NS
Liu 2009113RCT Prophylaxis[70–80]141451.9 [36–54]47.5 [41–65] ** ** ** 268 (42)485 (65)p<.01NRNRNR
Hendriks 2001114Cohort Prophylaxis8061243U [37–61]R48U [34–63]R3.0U [0–5]R9.0U [4–40]Rp=.002554598p=.26NRNRNR
De Gasperi 2005115Retrospective comparative Prophylaxis[20–40]6645 (4)47 (9)9 (4)7 (2.5)NSNRNRNRNRNRNR
Kalicinski 2005116Retrospective comparative Prophylaxis52 [30–100]286113 (4)11 (6) ^ ^ ^ 522 (110)534 (118)p=.357.03 (5.94)6.15 (5.55)p=.32
Neimann 2006117Retrospective comparative Prophylaxis58 (18)111148 (15)41 (17)3.9 (2.6)6.9 (2.3)p=.01416 (104)430 (84)p=.7 ## ## ##

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.

#

The majority of patients in Lodge 2005110 received 3 doses of either 60 or 120 ug/kg rFVIIa (range: 3–6 doses);

*

1 patient in the 180 ug/kg group and 2 patients in the 360 ug/kg group were excluded from the analysis;

**

Liu 2009113 does not report on RBC transfusion but does report blood loss: rFVIIa 2250 mL (SD 350), placebo 6214 mL (SD 750), p<0.01;

^

Total intraoperative blood transfusion volume (not isolated to RBCs): rFVIIa, 1980 mL; usual care, 1527 mL (NS);

##

Total hospital length of stay (not isolated to ICU length of stay): rFVIIa, 11 (SD 7.3) days; 7.9 (SD 2.7) days (p=0.2);

R

Denotes range instead of IQR;

U

Median; NR=not reported; NS=not significant; UC=usual care; “same” means that both studies stated, “No notable differences between study groups were found with respect to … operation duration,” (Lodge 2005110 and Planinsic 2005111) or that “The mean number of intensive care units days was comparable between studies.” (Lodge 2005110).

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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