Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration
- Conditions
- PHARMACOKINETICSFibrinogen; Deficiency, Acquired
- Registration Number
- NCT05503498
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.
- Detailed Description
Fibrinogen, a plasma-soluble protein synthesized by the liver, is the key substrate for the plasmatic blood coagulation, reaching a critically low plasma concentration earlier than other coagulation factors in case of bleeding. Fibrinogen Pharmacokinetics (PK) after single doses of fibrinogen concentrate (FC), using modeling approaches, has only been evaluated in congenital afibrinogenaemic patients. The aims of this study are to extend the modeling process to characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production. Influencing factors of differences on the fibrinogen PK between sub-populations will be identified.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION -
NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method plasma fibrinogen level JUNE 2021- AUGUST 2022 to develop a pharmacokinetic model to predict the plasma fibrinogen level after fibrinogen administration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hospital Clinic
🇪🇸Barcelona, Spain
Hospitla Clinic
🇪🇸Barcelona, Spain
Hospital Clinic🇪🇸Barcelona, Spain