Abstract
Introduction: Octacol F15 is a fibrin sealant, derived from human cryoprecipitate, which can be delivered as a spray that seals on contact. Pre-clinical studies have established its safety. The aim of this study was to determine the impact of Octacol F15 on blood loss in patients undergoing THR
Materials and Methods: The effect of Octacol F15 on 81 patients undergoing THR was studied in a randomised, prospective, multi-centres study. 38 patients received Octacol F15 delivered to the soft tissues around the hip at 3 predetermined times throughout the operation. 43 patients received a routine THR. Surgeons were constrained to use their predetermined approach, fixation method, and DVT prophylaxis. Blood loss was measured and transfusion needs recorded along with all adverse events.
Results: Mean blood loss in treatment patients was 699ml v 837ml in controls. Log transformed means adjusted for weight, surgeon and pre-operative haemoglobin showed a significant reduction in blood loss of 197ml or 23.5% (95% CI 5.4% to 38.1%) as an effect of treatment (p=0.014). Intra-operative blood loss was not significantly less in the treatment group (p=0.13) but post-operative blood loss was significantly reduced (p=0.0005). 11 treatment patients received blood transfusions (29%) against 18 controls (42%). This difference in transfusion needs was not significant (p=0.11). There was only one minor complication ‘possibly’ related to the use of Octacol F15.
Conclusion: Octacol F15 significantly reduces blood loss in THR without any increase in the complication rate. Its use in THR, particularly in procedures in which increased bleeding may be encountered, offers important clinical benefits.
The abstracts were prepared by Professor Jegan Krishnan. Correspondence should be addressed to him at the Flinders Medical Centre, Bedford Park 5047, Australia.
