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Table 38Applicability assessment of studies on liver transplantation

Describe Available EvidenceDescribe Overall Implications for Applicability
Patients undergoing orthotopic liver transplantation with Child’s class B or C cirrhosis
Mean age 50
Patients with abnormal clotting systems secondary to liver disease
There is no mention of Jehovah’s witness patients within the study populations
Exclusions: Patients who require transplantation for indications other than Child’s class B or C cirrhosis and/or who are on anticoagulation
rFVIIa use for this indication is very rare in U.S. but nonetheless the study findings are likely applicable to many of those undergoing liver transplantation, and may be relevant to select subgroups such as Jehovah’s witness patients, although such patients do not appear to have participated in the studies
Other approaches available to minimize blood loss
Prophylactic use of rFVIIa, either as a single dose of 20 to 80 mcg/kg prior to surgery, or as repeating doses for an aggregate dose of 213 or 412 mcg/kg.
Usual care, including transfusion protocol
Dose is variable, with high dose studies higher than for other prophylactic uses
Usual care via randomization or matched controlsOther prophylactic hemostatic agents potential comparators, but not used in this setting
Primary outcomes: Red blood cell transfusions over 24h and perioperative blood loss
Secondary outcomes: length of stay, operative time, thromboembolic events, coagulation lab parameters
Surrogate/indirect outcomes related to process of care without direct link to clinical outcomes
Insufficient sample size to meaningfully assess clinical outcomes
Quality of life or functional outcomes are absent
Timing and intensity of follow-up
Follow-up for duration of hospitalization Seldom had protocol for ascertainment of harmsLonger term outcomes and a protocol for ascertainment of harms is desirable
Academic hospitals in the U.S. and Western Europe that serve as regional referral centersHighly applicable to U.S. transplantation centers

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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