Status:
COMPLETED
PeproStat Haemostat Study in Subjects Undergoing Liver Surgery
Lead Sponsor:
Haemostatix Ltd
Conditions:
Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this First in Man study is to evaluate the safety and tolerability, as well as to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in patients undergo...
Eligibility Criteria
Inclusion
- Are able and willing to provide written informed consent to participate in this study, confirmed by signing the informed consent documents
- Adult males and females ≥18 years of age
- Female subjects must be post-menopausal. Post-menopausal status is defined as any of the following: natural menopause with menses \>1 year ago; radiation induced oophorectomy with last menses \>1 year ago; chemotherapy induced menopause with 1 year interval since last menses
- Willing and able to comply with all protocol requirements including follow-up
- Subject must have a haemoglobin ≥ 9.0 g/dL at screening
- Subject must have a platelet count ≥ 100,000/mm3 at screening
- Subject is undergoing a planned open liver resection
- Male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow-up visit
- During the surgery, the subject presents an identified target bleeding site (TBS) with oozing, mild or moderate bleeding, which conventional surgical techniques are insufficient to control and would otherwise be a candidate for standard haemostats
- During the surgery, subject presents no intraoperative complications, other than bleeding, that may interfere with study assessments as judged by the investigator
Exclusion
- Subject is undergoing emergency surgical procedure
- Recipient of a liver transplant
- Females of child-bearing potential
- Active infection at the time of the liver resection
- International Normalized Ratio (INR) \> 2.0 or APTT ratio \> 2.0 at screening
- Fibrinogen level \< 1.5g/L at screening
- History of thromboembolic disease and/or thrombophilia
- Any other disease or condition that may affect normal blood clotting, for example thrombocytopenia, as judged by the investigator
- A known history of anaphylaxis or allergic reaction to human albumin, PEGylated proteins, yeast or moulds, porcine products or other components in the IMP
- Participation in another investigational drug or device research study within 30 days before and after enrolment in the current study
- Current known or suspected alcohol and/or drug abuse or dependence at the time of screening
- 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
- During the surgery, subject presents severe bleeding where use of a topical haemostat would be inappropriate
- Subject is taking any prohibited medications
- BMI at screening of ≥35
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02204930
Start Date
July 1 2014
End Date
September 1 2015
Last Update
October 21 2015
Active Locations (4)
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1
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
2
Addenbrooke's University Hospital
Cambridge, United Kingdom, CB2 0QQ
3
Kings University Hospital
London, United Kingdom, SE5 9RS
4
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH