Phase 2 study investigating Fibrinogen Supplementation Sources
Research type
Research Study
Full title
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.
IRAS ID
216231
Contact name
Faheez Mohamed
Contact email
Sponsor organisation
Octapharma AG
Eudract number
2016-003749-27
Duration of Study in the UK
1 years, 6 months, 5 days
Research summary
The primary objective of this study is to investigate the ability of Fibrinogen concentrate (Octafibrin, a human blood-derived protein) to restrict or stop bleeding in patients that have reduced levels of Fibrinogen due to undergoing a surgical procedure (cytoreductive surgery) for Pseudomyxoma Peritonei (PMP). PMP is a rare type of cancer that starts as a small growth usually in the appendix. The growth then spreads cancerous cells to the lining of the abdominal cavity (the peritoneum). The cancerous cells produce mucus, which collects in the abdomen as a jelly like fluid. In this study the effect of Octafibrin will be compared with that of cryoprecipitate, a frozen blood product rich in blood-clotting factor used in standard practice for Fibrinogen supplementation.
The study will involve up to 55 adult patients all based in the UK undergoing cytoreductive surgery for PMP who require fibrinogen supplementation and are to be enrolled over a 12-month period. Patients will be randomised to two groups of 20 evaluable patients receiving either Octafibrin or cryoprecipitate. The duration of study participation per patient will be approximately 35 days. The study will be considered completed with 20 evaluable patients per group receiving either Octafibrin or cryoprecipitate.
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 during the surgery operation.
The overall assessment of the ability to stop bleeding during the surgery and at the end of surgery is made by both the surgeon and anaesthesiologist, a final assessment is made 24 hours after the end of surgery by the haematologist. It is based on an objective 4-point scale and will be adjudicated by the Independent Data Monitoring & Endpoint Adjudication Committee (IDMEAC) based on a pre-defined formula.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0576
Date of REC Opinion
18 Nov 2016
REC opinion
Favourable Opinion