Prospective, Randomised, Controlled Phase 2 Study Investigating the Haemostatic Efficacy and Safety of Fibrinogen Concentrate (Octafibrin) and Cryoprecipitate as Fibrinogen Supplementation Sources in Patients Undergoing Cytoreductive Surgery for Pseudomyxoma Peritonei. - Phase 2 study investigating Fibrinogen Supplementation Sources

Octapharma AG0 个研究点目标入组 45 人开始时间: 2018年6月29日最近更新: 2019年2月28日

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•Because the need for fibrinogen supplementation will not become apparent until 60–90 minutes into the surgery, the criteria for inclusion will be assessed at two separate time points, i.e., during screening and intraoperatively.
•Note: The maximum time allowed between the Screening Assessment and surgery is 1 week.
•Inclusion criteria checked during the Screening Assessment:
•1. Patients undergoing Sugarbaker procedure for PMP
•2. Age =18 years
•3. Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted
•4. Patient is capable to understand and comply with the relevant aspects of the study protocol.
•Inclusion criteria checked during the Intraoperative Assessments:
•5. Intraoperative need for fibrinogen supplementation as assessed on the basis of ‘bleeding risk assessment’ (i.e., predicted average intraoperative blood loss =2L)
•Patients not fulfilling inclusion criteria 5 will not be randomised and will be considered screening failures.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•All exclusion criteria will be assessed during screening. Patients who meet any of the following criteria are not eligible for the study:
•7. Recent history of thromboembolic disease (myocardial infarction, stroke, deep vein thrombosis, or pulmonary embolism within 2 months prior to screening)
•8. Known presence of chronic infections, such as infection with HIV or hepatitis C virus, as per medical history
•9. Undergoing emergency surgery
•10. Surgery for other forms of peritoneal malignancy or infection
•11. Receipt of fibrinogen-containing products within 14 days prior to screening.
•12. Patients with any known Ccongenital or acquired coagulation disorder (e.g., von Willebrand disease, haemophilia, or severe liver disease) or a prothrombotic disorder (e.g., protein C or S deficiency)
•13. Administration of a IIbIIIa antagonist within 1 day, clopidogrel within 5 days, ticagrelor within 2 days, and prasugrel within 7 days of screening
•14. Direct thrombin inhibitors within 3 days and factor Xa inhibitors within 2 days of screening
•15. Participation in another study within 30 days prior to screening
•16. Known hypersensitivity to the study medication
•17. Pregnant (based on urine pregnancy test) or lactating women

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