| Methods |
Patients were assigned to either the control or fibrin sealant groups by opening a sealed envelope that contained the randomisation code (allocated by a computer‐generated random sequence). The personnel recording data were blinded to the intervention received. No patients were withdrawn from the study. |
| Participants |
40 patients undergoing elective lobectomy were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant (n = 20), M/F = 9/11, mean age (+/‐SD) = 63.2 (12.8) years
(2) Control group (n = 20), M/F = 11/9, mean age (+/‐SD) = 65.3 (9.9) years |
| Interventions |
(1) Fibrin sealant group donated 120 ml of whole blood which was processed by the Vivostat® system. Fibrin sealant was applied over all areas at risk of air leaks and bleeding (all areas of dissection) with the lung deflated and without ventilation.
(2) Control group received standard care (no fibrin sealant was used). |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Blood loss (ml) ‐ 24‐hour post‐operative + total.
Length of hospital stay (days).
Air leakage (n).
Days with drain. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer‐generated random sequence |
| Allocation concealment? |
High risk |
C ‐ Inadequate (sealed envelopes contained randomisation code) |
| Blinding?
All outcomes |
Low risk |
Outcomes assessed blind |
