The Use of a Surgical Patch Coated With Human Coagulation Factors in Surgical Routine: A Multicenter Postauthorization Surveillance

Abstract

Local hemostyptic agents are of great value to significantly reduce bleeding complications and various devices have become available for clinical use. The aim of this multicenter postauthorization surveillance was to study the surgeons' expectations regarding efficacy and safety of the surgical patch coated with human coagulation factors (TachoSil) under routine clinical conditions. A total of 408 patients had been included in this trial and the patients had to have an expected increased bleeding risk either due to patient related hemorrhagic risk factors or operations associated with an expected increase of bleeding complications. The main types of surgical interventions were operations on the liver (26%), vascular system (16%), gastrointestinal tract (10%), heart (8%), kidney (7%), thorax (7%), spleen (4%), and pancreas (4%). Other operations (18%) were reported in the fields of neurosurgery, urology, gynecology, dermatology, and on the thyroid gland. Based on subjective assessments the results have shown that TachoSil has met the surgeons' expectations to be efficacious and safe as a hemostatic treatment in a broad variety of surgical interventions. The observed benefits far exceed the frequencies of complications and many of the observed benefits easily translate into cost savings. In almost 50% of the cases the surgeons thought that the use of the topical hemostat TachoSil may have led to savings in blood component therapy. The savings of intra- and postoperative transfusions may lead to less frequent transfusion-related adverse effects and the lower probability of postoperative complications is of clinical importance. In particular, it is worth mentioning that based on the surgeons' assessment, the use of TachoSil may have helped to save the organ in 17% of the cases. Thus, these clinically relevant benefits may offer opportunities for improvements of hemostasis in patients at risk for bleeding complications and may facilitate the management of excessive bleeding.