Table 33Applicability assessment of studies on brain trauma

Describe Available EvidenceDescribe Overall Implications for Applicability
Population
Patients experiencing traumatic brain injury with CT confirmed hematoma > 2 cc (initially set at 5 cc)
Includes subdural and subarachnoid hemorrhage, as well as intracerebral hemorrhage
Patients primarily with intact clotting systems
Mean age 50
Exclusions: Most patients on anticoagulation
The population included may be infrequent in clinical practice, especially outside of major regional referral centers for trauma
As with non-traumatic causes of intracranial hemorrhage, other advances may make rFVIIa less important in the future
Intervention
A single treatment dose of 40 to 200 mcg/kg upon confirmation of intracranial hemorrhage
Usual care, including transfusion protocol
Lack of apparent dose-response relationship reduces possible guidance on dose selection
Comparator
Usual care via randomization or matched controlsOther prophylactic hemostatic agents potential comparators, but not used in this setting
Outcomes
Primary outcomes: Time to neurosurgical intervention
Secondary outcomes: mortality, thromboembolic events, hematoma volume change, GCS score
Surrogate/indirect outcomes related to process of care without direct link to clinical outcomes
Insufficient sample size to meaningfully assess clinical outcomes
Timing and intensity of follow-up
Follow-up for 15 days after injury
Had detailed protocol for ascertainment of thromboembolic events in the RCT
Longer term outcomes desirable
Setting
Highly specialized trauma centers in Canada, Germany, Israel, Finland, Italy, Switzerland, Taiwan and Singapore, and Baltimore, MDLikely applicable to similar U.S. trauma centers despite some variations in practice

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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