| Methods |
Methods of randomisation and allocation concealment were not described. Study was described as being single‐blinded. |
| Participants |
24 patients undergoing elective primary coronary artery bypass surgery were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant group (n = 12).
(2) Control group (n = 12).
NB: Mean age of the participants was 62.4 years (range = 44 to 77 years); M/F = 22/2. |
| Interventions |
(1) Fibrin sealant group received autologous FS, obtained using the Vivostat® system, applied with a spray system at the end of the operation, after reversal of heparin with protamine. FS was applied at any bleeding sites after conventional haemostasis was performed. Additionally it was applied at the anastomoses, the mammary pedicle, the mediastinum, and the sternal marrow.
(2) Control group received conventional haemostasis only. No FS was used.
NB: All patients received 3 drains: a pericardial drain, a retrosternal drain, and a left pleural drain. Autotransfusion of shed mediastinal and pleural blood was used post‐operatively for all patients. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Blood loss (ml).
Mortality (n).
Adverse events (n).
Re‐operation due to bleeding (n). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
High risk |
Method of randomisation was not reported |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
High risk |
Single blind ‐ patients only |
