The effect of haemostatic factor,Octafibrin in congenital afibrinogenemia
- Conditions
- Congenital Afibrinogenemia.Hereditary deficiency of other clotting factors?D68.2
- Registration Number
- IRCT2014112320051N3
- Lead Sponsor
- Octapharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 3
Inclusion:
age 6-12; documented diagnosis of congenital fibrinogen deficiency; Historical plasma fibrinogen activity of <50ml/dl; expected to have an acute bleeding episode(spontaneous or after trauma) or planing to undergo elective surgery; Informed consent signed by the subject's legal guardian
Exclusion:
Life expectancy<6 months; bleeding disorder other than congenital fibrinogen dificiency; prophylactic treatment with a fibrinogen concentrate; any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks prior to start of treatment for the PK phase,a bleeding episode, or surgery; any coagulation drug within 1 week prior to start of PK phase or treatment for the bleeding episode or surgery, or as a planned or expected medication during the time period from Day 1 until 24 hourspresence or history of hypersensitivity to study medication,DVT or pulmonary embolism, arterial thrombosis within 1 year prior to start drug infusion,hypersensitivity to human plasma protein,Oesophageal varicose bleeding
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall clinical assessment of the haemostatic efficacy of Octafibrin. Timepoint: 24 hours. Method of measurement: 4-point haemostatic efficacy scale.
- Secondary Outcome Measures
Name Time Method ‘clot strength’ or ‘clot firmness’. Timepoint: 1 hour. Method of measurement: blood sampling.