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Table 29Applicability assessments of studies of body trauma

Available EvidenceOverall Implications for Applicability
Population
Patients presenting bleeding secondary to blunt or penetrating trauma requiring massive transfusion of RBCs (variably defined) prior to rFVIIa dose Patients with coagulopathy of trauma
Mean age 32
Exclusions: In several studies, patients who died within 24h or 48h (censoring point varies with study) or with symptoms/signs indicating grave prognosis
The population included may be infrequent in clinical practice, especially outside of major regional referral centers for trauma.
Community practice may involve greater use of rFVIIa as end-stage therapy in patients with poor prognosis
Intervention
As series of treatment doses of 200, 100 and 100 mcg/kg during treatment for trauma
Transfusion protocol in place at most sites
RCT dose is relatively high compared to other studies
Comparator
Usual care via randomization or matched controls
Studies implemented prior to current consensus regarding 1:1 ratio of transfusion products and implementation of institutional massive transfusion protocols
Other prophylactic hemostatic agents potential comparators, but not used in this setting
Usual care has likely changed moderately since the studies were conducted.
Outcomes
Primary outcomes: RBC transfusion requirements in RCTs (over 48 hours) and patient mortality
Secondary outcomes: thromboembolic events, ARDS
Surrogate/indirect outcomes without necessary link to clinical outcomes
Mortality outcomes less applicable due to censoring (need to survive 24h or 48h post-trauma (censoring point varies with study))
Insufficient sample size to meaningfully assess other clinical outcomes Quality of life or functional status measures absent
Timing and intensity of follow-up
Follow-up for duration of hospitalization, one COBS with 30-day mortality information
Detailed protocol for ascertainment of MI and DVT
Longer term outcomes desirable
Setting
Highly specialized trauma centers in Australia, Canada, France, Germany, Israel, Singapore, South Africa, and U.K., as well as a combat support hospital in IraqExperience likely similar to specialized U.S. trauma centers, but some cross-national differences likely exist, and military hospitals may also differ from civilian ones

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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