| Methods |
Patients were randomised using a block design with permutated block of 5, which was concealed until interventions were assigned. All patients completed follow up. All the patients and staff, except those directly administering the fibrin sealant, were blinded to the treatment, including those assessing and collecting the post‐operative measurements, investigations and outcomes. |
| Participants |
150 patients undergoing elective total knee replacement were randomly allocated to 1 of 3 groups:
(1) Fibrin sealant group (n = 50).
(2) Tranexamic acid group (n = 50).
(3) Control group (n = 50).
NB: Demographic data not reported. |
| Interventions |
(1) Fibrin sealant group received 10 mls of reconstituted fibrin sealant (Quixil; Johnson & Johnson Wound Management, Somerville, New Jersey, US) intra‐operative with 6 ml sprayed on to the posterior capsule and surrounding soft tissues before the prosthesis was inserted, and the remaining 4 ml sprayed onto the bone which was exposed after placement of the prosthesis and on the soft tissues after closure of the capsule.
(2) Tranexamic acid group received 500 mg of intravenous TXA 5 minutes before deflation of the tourniquet and a repeat dose 3 hours later.
(3) Control group received no pharmacological intervention. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Amount of allogeneic blood transfused (units).
Blood loss (ml) ‐ total blood loss.
Mortality (n).
Wound infection (n).
Length of hospital stay (days).
Deep venous thrombosis (n).
Pulmonary embolus (n). |
| Notes |
All patients received 150 mg of aspirin (ASA) as a single dose the evening before surgery and daily for 6 weeks post‐operatively. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Method of randomisation was not reported |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
High risk |
Outcomes were assessed blind |
