| Methods |
Sealed envelopes were used to conceal treament allocation. Randomisation was performed using a random number table. Blinding was not described. |
| Participants |
47 patients undergoing elective carotid endarterectomy and expanded polytetrafluoroethylene carotid patch angioplasty were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant group (n = 24), M/F = 15/9.
(2) Control group (n = 23), M/F = 18/5.
NB: Mean age (+/‐SD) age of the participants was 67.7 (6) years. |
| Interventions |
(1) Fibrin sealant group were treated with solvent‐detergent treated human FS (Baxter Healthcare) containing purified human fibrinogen and purified human thrombin. The FS was applied as a liquid using a dual syringe technique with 3 ml of each of the two main components (fibrinogen and thrombin).
(2) Control group were treated with thrombin‐soaked gelatin (TSG) sponge (Gelfoam, Upjohn). The Gelfoam was cut into 1.0 x 3.0 cm strips before application. Bovine thrombin solution was applied to the wafers of the Gelfoam. |
| Outcomes |
Blood loss (ml) ‐ intra‐operative estimated blood loss.
Time to haemostasis (min).
Stroke (n).
Wound complications (n).
Pre‐post Hb levels.
Transient ischemic attacks (n).
Mortality (n).
Biochemical data. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Random number table |
| Allocation concealment? |
High risk |
C ‐ Inadequate (sealed envelopes) |
| Blinding?
All outcomes |
Unclear risk |
Not reported |
