PeproStat as a Topical Agent Used to Stop Bleeding in Patients Undergoing Surgery

This is an interventional treatment trial for Bleeding Read More

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.