A novel collagen-based composite offers effective hemostasis for multiple surgical indications: Results of a randomized controlled trial

Background. Intraoperative bleeding is ubiquitous during open surgical proc edures and uniformly effective hemostasis remains elusive. We conducted a r andomized controlled trial to determine the effectiveness of a novel collag en-based composite (CoStasis Surgical Hemostat) compared with standard meth ods of hemostasis during general, hepatic, cardiac, and orthopedic operatio ns. Methods. Hemostatic treatment was assigned randomly to 347 subjects; 318 su bjects (167 CoStasis, 151 controls) underwent operation, received treatment , and provided hemostatic success data. CoStasis was applied to the bleedin g site without manual pressure as a sprayable liquid composite of bovine mi crofibrillar collagen, bovine thrombin, and autologous plasma. Manual compr ession was used as the control hemostat. Hemostatic success was achieved if bleeding had ceased completely within 10 minutes (3 minutes for cardiac su bjects). The time to controlled bleeding (ie, slight oozing) and time to co mplete hemostasis were recorded for all subjects. Results. Hemostatic success was achieved in more than 90% (153/167) of CoSt asis subjects compared with 58% (88/151) of control subjects (P = .01). Sup erior hemostatic effectiveness with CoStasis was realized in every surgical specialty: general (77/79 vs 49/75, P = .01), hepatic (38/39 vs 20/29, P = .01), cardiac (28/37 vs 17/37, P = .02), and orthopedic (10/12 vs 2/10, P = .01). The duration of bleeding was also significantly shorter with CoStas is. The median time to controlled bleeding (42 seconds vs 150 seconds, P = .0001) and time to complete hemostasis (75 seconds vs 252 seconds, P = .000 1) were both markedly longer with the control intervention. There were no s erious adverse events related to the use of CoStasis. Conclusions. CoStasis is more effective at controlling and stopping diffuse intraoperative bleeding than standard methods of hemostasis in 4 distinct surgical indications representing a wide variety of operative interventions .