Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

Completed

• Conditions: PHARMACOKINETICS; Fibrinogen; Deficiency, Acquired
• Interventions: Other: DATA RECORDING

• 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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Status Verified: 2022-08
• Study Completion: 2022-08-01
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-12
• Last Update Submitted: 2022-08-12
• Study First Posted: 2022-08-16
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION -

Exclusion Criteria

NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AFIBRINOGENEMIA, CIRRHOSIS, TRAUMATICS	DATA RECORDING	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

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

Trial Locations

Locations (2)

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospitla Clinic; 🇪🇸 Barcelona, Spain