Table 53Applicability assessment of study on prostatectomy

Describe Available EvidenceDescribe Overall Implications for Applicability
Population
Two distinct populations are studied:
-Retropubic prostatectomy for cancer
-Retropubic prostatectomy for benign hyperplasia
-Patients with intact clotting system
Exclusions: Patients on anticoagulation
rFVIIa use for this indication very rare in U.S. and evidence is not relevant Transfusion requirements and blood loss are much higher for the control group than they are in the general population of patients undergoing prostatectomy
Intervention
Prophylactic use of rFVIIa at 20 or 40 mcg/kg Usual care, including transfusion protocolDose is low compared to use as treatment or even to prophylactic use in other indications
Comparator
Usual care via randomizationAdvances in usual care have led to the application of other surgical approaches that minimize blood loss (e.g., TURP, laparoscopic surgery) Other prophylactic hemostatic agents potential comparators, but not used in this setting
Outcomes
Primary outcomes: Red blood cell transfusions 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
Timing and intensity of follow-up
Follow-up for duration of hospitalization (but with long, 10 day stays)
Detailed protocol for ascertainment of MI and DVT
Longer term outcomes would be desirable
Setting
An academic hospital in the NetherlandsMay have limited applicability to U.S. practices

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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