Fibrinogen (blood protein) supplementation in patients that have developed fibrinogen deficiency during surgery.
- Conditions
- 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 10037138 Term: Pseudomyxoma peritonei System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2016-003749-27-GB
- Lead Sponsor
- Octapharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method