Fibrinogen; Deficiency, Acquired, PHARMACOKINETICS
Conditions
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.
Interventions
OTHERDATA RECORDING
RECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION
Sponsors
University of Barcelona
Hospital Clinic of Barcelona
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION -
Exclusion criteria
NA \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma fibrinogen level | JUNE 2021- AUGUST 2022 | to develop a pharmacokinetic model to predict the plasma fibrinogen level after fibrinogen administration |
Countries
Spain
Outcome results
None listed