NCT05503498

Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

Population Pharmacokinetic Modeling of Fibrinogen in Patients With Congenital or Acquired -Chronic or Acute- Hypofibrinogenemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Fibrinogen; Deficiency, Acquired
• PHARMACOKINETICS

Interventions

Type	Name	Description
OTHER	DATA RECORDING	RECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-01-01
• Completion: 2022-08-01
• First posted: 2022-08-16
• Last updated: 2022-08-16

Locations

2 sites across 1 country: Spain