| Methods |
Patients were randomised to intervention or control by means of a computer‐generated randomisation list. Blinding was not described. Method used to conceal treatment allocation was not described. |
| Participants |
100 female patients undergoing elective total hip arthroplasty were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant group (n = 50), mean age (+/‐SD) = 60 (11) years.
(2) Control group (n = 50), mean age (+/‐SD) = 60 (10) years. |
| Interventions |
(1) Fibrin sealant group: whole blood was collected and centrifuged. Separated plasma was collected and stored at ‐40 °C and then thawed by storage at 4 °C for 24 hours. The freeze‐and‐thaw process was repeated twice. The plasma was centrifuged after the second thawing and an autologous cryoprecipitate (auto‐Cryo) was obtained. The auto‐Cryo was stored at ‐40 °C and thawed just prior to surgery (Solution A). Solution A was delivered to the operating room where Solution B (thrombin 5000 IU, 5 ml of 2% calcium chloride, aprotinin 50,000 IU) was prepared. Solutions A and B were individually filled into a double‐syringe spray device and used as auto‐FTA. The volume auto‐FTA (autologous fibrin sealant) was approximately 10 ml.
(2) Control group: received standard treatment without fibrin sealant treatment. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Blood loss (ml) ‐ total blood loss.
Blood loss (ml) ‐ 24 and 48 hours post‐operative blood loss.
Infection (n).
Deep venous thrombosis (n).
Pulmonary embolus (n). |
| Notes |
All patients were able to donate 400 ml of whole blood 3 weeks prior to surgery without the need for erythropoietin (EPO). Patients then received oral iron supplements (200 mg ferrous fumarate) for 3 weeks. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer‐generated randomisation |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
Unclear risk |
Not reported |
