The sequence of events culminating in Pseudomyxoma peritonei (PMP) is thought to involve growth of an appendiceal adenoma with distension of the appendix by mucus and mucinous tumour cells. The appendix eventually ruptures. Patients undergoing the PMP surgery develop a coagulopathy predominantly characterised by reduced levels of fibrinogen, resulting in reduced whole blood clot firmness. MedDRA version: 20.0 Level: PT Classification code 1003713
Conditions
Interventions
Product Name: Octafibrin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Fibrinogen
Concentration unit: mg milligram(s)
Sponsors
Octapharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the overall (i.e. intra- and postoperative) haemostatic efficacy (ability to stop bleeding) of Octafibrin, a human blood-derived protein with that of cryoprecipitate in bleeding patients developing acquired fibrinogen deficiency during removal of tumour growth from the abdomen (cytoreductive surgery) for Pseudomyxoma Peritonei (PMP).; Secondary Objective: The secondary objectives of the study are: To compare the intraoperative haemaostatic efficacy (ability to stop bleeding) of Octafibrin with that of cryoprecipitate in bleeding patients developing acquired fibrinogen deficiency during removal of tumour growth from the abdomen (cytoreductive surgery) for Pseudomyxoma Peritonei (PMP). To compare the postoperative haemostatic efficacy by study group To compare the capability of Octafibrin with that of cryoprecipitate to correct the acquired fibrinogen deficiency in the study population as demonstrated by an increase in Clauss plasma fibrinogen concentration. To analyse dose and duration of fibrinogen supplementation by study group. To assess the coagulation (change of blood to semi solid state) profiles by study group. To analyse critical care outcome data by study group. To determine the time to availability of Octafibrin and cryoprecipitate in the operating room. To investigate the safety profile of Octafibrin or cryoprecipitate ; Primary end point(s): The primary objective is to compare the overall (i.e. intra and postoperative) haemostatic efficacy of Octafibrin with that of cryoprecipitate in bleeding patients developing acquired fibrinogen deficiency during cytoreductive surgery for pseudomyxoma peritonei. The primary efficacy endpoint is the overall haemostatic efficacy rating as assessed by the Independ | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Intra operative haemostatic efficacy of Octofibrin and cryoprecipitate in controlling intraoperative bleeding as assessed at the end of surgery by the surgeon and anaesthesiologist using an objective 4-point haemostatic efficacy scale (see response above). Postoperative haemostatic efficacy of Octafibrin and cryoprecipitate in controlling postoperative bleeding as assessed 24 hours after the end of surgery by the haematologist using an objective 4-point scale. Capability of Octafibrin and cryoprecipitate to correct the acquired fibrinogen deficiency as demonstrated by an increase in Clauss plasma fibrinogen concentrations after the first post-randomisation infusion (i.e. preemptive dose). ;Timepoint(s) of evaluation of this end point: Intraoperative haemostatic efficacy is assessed at the end of surgery by both the surgeon and the anaesthesiologist. Postoperative haemostatic efficacy is assessed 24 hours after the end of surgery by the haematologist. | — |
Countries
United Kingdom
Contacts
Public ContactIrina Kruzhkova
Octapharma AG
Outcome results
None listed