Surgical procedures in patients with afibrinogenaemia and severe hypofibrinogenaemia MedDRA version: 9.1 Level: LLT Classification code 10052651 Term: Afibrinogenaemia MedDRA version: 9.1 Level: LLT Classification code 10051125 Term: Hypofibrinogenaemia
Conditions
Interventions
Product Name: Human fibrinogen
Product Code: FTG1
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Human fibrinogen
Current Sponsor code: FGT1
Concentration unit:
Sponsors
LFB SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent form 2. Inherited afibrinogenaemia defined as no detectable plasma fibrinogen or severe hypofibrinogenaemia defined as plasma fibrinogen activity =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Dysfibrinogenemia or acquired fibrinogen deficiency 2. Antibodies against fibrinogen or fibrinogen inhibitor 3. Surgery requiring fresh frozen plasma 4. History of venous or arterial thrombosis 5. Patient presenting any one of the following indicators of thrombophilia or associated bleeding disorders: - Activated protein C resistance control /patient 9 minutes (standardised Ivy incision) - Thrombin Time > 17 seconds - Lupus anticoagulant (LA-aPTT) patient/control > 1.55 - Dilute Russell's Viper Venom Time (LA-dRVVT) patient/control > 1.3 6. Platelets less than 100G/l 7. AST and ALT > 5 times the upper limit of normal 8. Known history of hypersensitivity or other severe reaction to any component of the investigational medicinal product 9. Patient presenting renal insufficiency or diabetes 10. Treatment with any other investigational medicinal product 11. Previously included in this study for the same procedure 12. Drug or alcohol abuse 13. Inability to tolerate the required fluid infusion volume according to the Investigator’s judgement 14. Patient whose use of concomitant medication may interfere with the interpretation of data 15. Patient with abnormalities on physical examination or laboratory results that, in the opinion of the Investigator, are deemed to be clinically significant 16. Severe comorbidity that in the opinion of the Investigator could jeopardise patient’s safety 17. Pregnancy or breastfeeding 18. Anticipated poor compliance with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of FIBRINOGENE T-I administered for peri-operative prophylaxis of bleeding during surgery in patients with afibrinogenaemia or severe hypofibrinogenaemia.;Secondary Objective: The secondary objectives of the study are: - to document the clinical postoperative healing of the patients, - to assess the safety of FIBRINOGENE T-I in patients with afibrinogenaemia or hypofibrinogenaemia.;Primary end point(s): The primary end-point to assess efficacy is the 4-point scale defined as follows: - Excellent: clinical normalisation of haemostasis, i.e. comparable to a patient with no bleeding disorder - Good: mildly increased bleeding compared to a patient with no bleeding disorder - Moderate: moderately increased bleeding compared to a patient with no bleeding disorder - None: severely increased bleeding compared to a patient with no bleeding disorder | — |
Countries
France
Outcome results
None listed