PKMF: Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

• Sponsor: Hospital Clinic of Barcelona (Other)
• Overall Status: Completed
• CT.gov ID: NCT05503498
• Collaborator: University of Barcelona (Other)
• Enrollment: 200
• Locations: 2
• Actual Duration (Months): 19
• Patients Per Site: 100
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fibrinogen; Deficiency, Acquired; PHARMACOKINETICS	Other: DATA RECORDING

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 Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Population Pharmacokinetic Modeling of Fibrinogen in Patients With Congenital or Acquired -Chronic or Acute- Hypofibrinogenemia
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Jan 1, 2022
• Actual Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
AFIBRINOGENEMIA, CIRRHOSIS, TRAUMATICS 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	Other: DATA RECORDING; RECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION

Outcome Measures

Primary Outcome Measures

1. plasma fibrinogen level [JUNE 2021- AUGUST 2022]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Exclusion Criteria: NA

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinic	Barcelona		Spain	08037
2	Hospitla Clinic	Barcelona		Spain

Sponsors and Collaborators

• Hospital Clinic of Barcelona
• University of Barcelona

Investigators

• Principal Investigator: ANNABEL NA BLASI, PMPHD, Hospital Clinic of Barcelona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Annabel Blasi, principal investigator, Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT05503498
• Other Study ID Numbers: PMODEL
• First Posted: Aug 16, 2022
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 16, 2022