Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery

Exclusion Criteria

• •Required surgical procedure due to trauma (except for spinal surgery).
• •Infection in the anatomic surgical area.
• •History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived (human or animal) product.
• •Previous known sensitivity to any Topical Thrombin (Human) Grifols component, any Bovine Thrombin JMI component, porcine collagen, and heparin or protamine (vascular surgery only) component.
• •Received an organ transplant.
• •Underwent another concurrent major surgical intervention beyond the liver (applied to hepatic surgery \[IG1202-B\] only; concurrent interventions on the pancreas, gall bladder, bile duct, or intestines were allowed).
• •Underwent a re-operative procedure, which was defined as a second, or successive, surgical procedure on the same anatomic location.
• •Underwent other vascular procedures during the same surgical session (applied to vascular surgery \[IG1202-A\] only; stenting and/or endarterectomy of the same artery were allowed).
• •Underwent a therapeutic surgical procedure within 30 days from screening (diagnostic procedures were allowed).
• •Previously included in this trial (i.e. each subject could only be enrolled once in this study).
• •TBS could not be identified according to the investigator's judgment.
• •TBS had a severe bleeding according to the Investigator's judgment.
• •Occurrence of major intra-operative complications that required resuscitation or deviation from the planned surgical procedure.
• •Application of any topical haemostatic material on the resection surface of the liver prior to application of the study treatment (applied to hepatic surgery \[IG1202-B\] only).
• •Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary haemostatic treatment (applied to hepatic surgery \[IG1202-B\] only).
• •Application of any topical haemostatic material on the cut soft tissue surface prior to application of the study treatment (applied to soft tissue surgery \[IG1202-C\] only).