To achieve haemostasis when bleeding cannot be controlled by conventional methods alone, such as manual pressure, cauterization, or sutures
Conditions
Interventions
Product Name: PeproStat
Pharmaceutical Form: Solution for sealant
INN or Proposed INN: GPRPG-rHA conjugate
Current Sponsor code: HXSA902
Sponsors
Haemostatix Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) have to use highly effective methods of contraception from enrollment through to the 30 day follow-up visit. Such methods include: Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable. Intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
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 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, HBV or HCV infection. 12. During the surgery, subject presents severe bleeding where use of a topical haemostat would be inappropriate. 13. Anti-platelets/oral anticoagulants treatment: a. Soft tissue/liver and neurosurgery: Subject is taking anti-platelet agents or oral anticoagulants within 7 days of surgery. b. 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: a. Soft tissue/liver and neurosurgery only: Subject is receiving therapeutic doses of heparin perioperatively. Only prophylactic LMWH is allowed. 15. Pregnant or breast-feeding subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of PeproStat in intraoperative hemostasis in adult subjects who undergo open liver/soft tissue surgery, vascular surgery or spine surgery;Secondary Objective: The secondary objective is to further investigate the safety of PeproStat;Primary end point(s): The primary endpoint of the study is the investigation of efficacy in terms of Time to haemostasis, mean (mTTH) at the primary target bleed site (TBS), measured in minutes (min) from the start of treatment application (TxStart) at the TBS to the achievement of haemostasis at that site or to the end of the 10-minute assessment period if haemostasis has not yet been achieved. If haemostasis is not achieved within 10 minutes at the primary TBS, the patient is considered a treatment failure.;Timepoint(s) of evaluation of this end point: During the surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints, efficacy: 1. Percentage of subjects achieving hemostasis at 1, 2, 3, 5, 7 & 10 min; 2. Median time to hemostasis in minutes from TxStart to the achievement of hemostasis or to the end of the 10-minute assessment period if hemostasis has not yet been achieved; 3. Number/rate of subjects who do not achieve hemostasis within 10 min; 4. Number and size (if cut to size) of sponges applied at TBS, i.e., 1 or 2 sponges at TBS; 5. Dose of PeproStat determined by number and size of PeproStat soaked sponges applied at TBS; 6. Number/rate of treatment failures: Subjects not having obtained hemostasis within the 10-minute assessment period (primary, secondary and both TBS); 7. Use of alternative hemostatic agents at the TBS; 8. Investigator assessment of efficacy to obtain haemostasis (scale of 1-5, where 5 is very effective); 9. Investigator assessment ease of use of study treatment (score 1 – 5 where 5 is very easy to use). Secondary endpoints, safety: 10. Adverse events (AEs) including adverse events of special interest: Bleeding at the TBS after 10-minute assessment period during or after surgery (if re-operation is required) and transfusion requirement; 11. Antiplatelet/ heparin usage; 12. Laboratory safety parameters; 13. Immunogenicity testing; 14. Vital signs: heart rate (HR), blood pressure (BP), respiratory rate (RR); arterial oxigenation (pulse oximetry, PO); 15. 12-lead electrocardiogram (ECG). ; Timepoint(s) of evaluation of this end point: 1,2,3,5,7 and 10 minutes | — |
Countries
Bosnia and Herzegovina, Croatia, Germany, Poland, Serbia, Ukraine, United Kingdom
Contacts
Public ContactInformation point
Haemostatix Limited
Outcome results
None listed