Clinical trial NCT03131336 (phase 2, status: completed)
Conditions: bleeding
ICD codes: N92.3, N95.0, K29.80, K29.81, I85.00, I85.01, K20.80
Drugs: peprostat, saline
SMILES: COCCC1=CC=C(OCC(O)CNC(C)C)C=C1
Eligibility criteria:

        Inclusion Criteria: At screening and baseline:

          1. Subject is undergoing a planned open liver/soft tissue surgery, vascular surgery or
             spine surgery.

          2. Subjects are able and willing to provide written informed consent to participate in
             this study.

          3. Adult males and females ≥18 years of age at screening.

          4. Willing and able to comply with all protocol requirements including follow-up
             assessments.

          5. Male subjects must be willing and able to use adequate contraception from enrollment
             through to the 30 day follow-up visit.

          6. Women of childbearing potential (WCBP)C have to use highly effective methods of
             contraception from enrollment through to the 30 day follow-up visit.

             Intraoperative:

          7. The subject presents an identified target bleeding site with mild or moderate
             bleeding, which conventional surgical techniques are insufficient to control or are
             inappropriate and would otherwise be a candidate for standard haemostats.

          8. The subject presents no intraoperative complications, other than bleeding, that may
             interfere with study assessments as judged by the Investigator.

          9. The subject presents no contaminated areas of the body, signs of infection or abscess
             development.

         10. Total target bleeding site surface area of ≤ 70 cm2, defined within one or two TBSs.

        Exclusion Criteria:

          1. Subject is undergoing emergency surgical procedure.

          2. Use of study treatment and sponge in

               -  Closure of skin incisions as the sponge may interfere with the healing of skin
                  edges.

               -  Intravascular compartments because of the risk of embolization following sponge
                  application.

          3. Recipient of an organ transplant.

          4. Haematologic, biochemistry and coagulation panel thresholds at screening:

               -  Haemoglobin ≤ 9.0 g/dL.

               -  Platelet count ≤100,000/mm3 (≤ 100 x 109/L).

               -  International Normalized Ratio (INR) > 2.0 or activated Partial Thromboplastin
                  Time (aPTT) ratio > 2.0.

               -  Fibrinogen level < 1.5 g/L.

               -  Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) ≥ 3 times the
                  upper limit normal range, except for subjects undergoing liver resection surgery
                  where there is no upper limit for these analytes due to the nature of their
                  disease.

          5. Severe renal failure.

          6. Any other disease or condition that may affect normal blood clotting, for example
             thrombocytopenia, as judged by the Investigator.

          7. A known history of anaphylaxis or allergic reaction to human albumin, PEGylated
             proteins, yeast or moulds, porcine products or other components in the study
             medication or sponge.

          8. Participation in another investigational drug or device research study within 30 days
             before and after enrolment in the current study.

          9. Current known or suspected alcohol and/or drug abuse or dependence at the time of
             screening.

         10. Any concurrent medical, surgical, or psychiatric condition that may, in the
             Investigator's opinion, affect the subject's willingness or ability to meet all study
             requirements during the study duration.

         11. Known HIV, Hepatitis B virus or Hepatitis C Virus infection.

         12. During the surgery, subject presents severe bleeding where use of a topical haemostat
             would be inappropriate.

         13. Anti-platelets/oral anticoagulants treatment:

               1. Soft tissue/liver and neurosurgery: Subject is taking anti-platelet agents or
                  oral anticoagulants within 7 days of surgery

               2. Vascular surgery: Subject is taking dual anti-platelet treatment or oral
                  anticoagulants within 7 days of surgery. One anti-platelet agent is allowed
                  perioperatively.

         14. Heparin treatment:

             c. Soft tissue/liver and neurosurgery only: Subject is receiving therapeutic doses of
             heparin perioperatively. Only prophylactic Low Molecular Weight Heparin is allowed.

         15. Pregnant or breast-feeding subject.