Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration (PKMF)

Hospital Clinic of Barcelona

Status: Completed

Conditions: Fibrinogen; Deficiency, Acquired; PHARMACOKINETICS

Treatments: Other: DATA RECORDING

Study type: Observational

Funder types: Other

Identifiers

NCT05503498

PMODEL

Details and patient eligibility

About

characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.

Full 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.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION -

Exclusion Criteria: NA

Trial design

200 participants in 1 patient group

AFIBRINOGENEMIA, CIRRHOSIS, TRAUMATICS

Description:

PATIENTS WITH CONGENIAL AFIBRINOGENEMIA:RECORD OF PLASMA FIBRINOGEN LEVEL PATIENTS WITH ADQUIRED CRONIC HIPOFIBRINOGENEMIA AND END STAGE OF THE LIVER DISEASE: RECORD OF PLASMA FIBRINOGEN LEVEL PATIENTS WITH ADQUIRED ACUTE HIPOFIBRINOGENEMIA AND ACUTE TRAUMA: RECORD OF PLASMA FIBRINOGEN LEVEL

Treatment:

Other: DATA RECORDING