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OpenTrials
Completed

NCT Number: NCT05503498

Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

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

Completed

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Key information

Conditions

Fibrinogen; Deficiency, Acquired Pharmacokinetics

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinic, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION -

Exclusion criteria

NA

-

Treatment and study plan

DATA RECORDING

Other

RECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION

Primary outcomes

  1. plasma fibrinogen level

    Time frame: JUNE 2021- AUGUST 2022

    to develop a pharmacokinetic model to predict the plasma fibrinogen level after fibrinogen administration

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • University of Barcelona

Registry information

Official study title

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

Acronym: PKMF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2022
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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