Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery
Condition: Hemostasis
Intervention: Human thrombin; Bovine thrombin
Intervention description: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges; Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
Intervention MeSH terms: Thrombin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Healthy volunteers: No
Keywords: Vascular surgery; Hepatic surgery; Soft tissue surgery; Spinal surgery

Summary:

      This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin
      (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft
      tissue, and spinal surgical procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-operative (at Baseline Assessments Visit) hemoglobin (Hgb) ≥9.0 g/dL (deciliter)

          -  Pre-operative (at Baseline Assessments Visit) fibrinogen level ≥150 mg/dL (functional
             method).

          -  Required one of the following procedures:

               1. An elective (non-emergency), open (non-laparoscopic; non- endovascular) surgical
                  procedure involving a native artery-graft end-to-side proximal anastomosis
                  utilizing coated or uncoated polytetrafluoroethylene (PTFE) graft (IG1202-A).

               2. An elective (non-emergency), open (non-laparoscopic) hepatic resection (anatomic
                  and non-anatomic resections of at least one anatomical hepatic segment or
                  equivalent tissue volume) (IG-1202-B).

               3. An elective (non-emergency), open (non-laparoscopic), surgical procedure
                  involving soft (non-parenchymous) tissue (IG1202-C).

               4. An elective (non-emergency), spinal surgical procedure in which the epidural
                  venous plexus was exposed (IG1202-D).

          -  A target bleeding site (TBS) was identified according to the Investigator's judgment,
             and the TBS had mild or moderate bleeding according to the Investigator's judgment.

        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).

          -  Intra-operative change in planned surgical procedure which resulted in subject no
             longer meeting preoperative inclusion and/or exclusion criteria.

          -  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).