Pharmacokinetic Model of Fibrinogen Plasma Levels After F... | NCT05503498

Studies
Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

NCT05503498

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Aug 16, 2022Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Fibrinogen; Deficiency, Acquired
PHARMACOKINETICS

Interventions

DATA RECORDING

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Aug 1, 2022Actual

First Submitted Date

Aug 11, 2022

First Submission Date that Met QC Criteria

Aug 12, 2022

First Posted Date

Aug 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2022

Last Update Posted Date

Aug 16, 2022Actual

Name	Class
University of Barcelona	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DATA RECORDING	Other	RECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION	AFIBRINOGENEMIA, CIRRHOSIS, TRAUMATICS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
plasma fibrinogen level	to develop a pharmacokinetic model to predict the plasma fibrinogen level after fibrinogen administration	JUNE 2021- AUGUST 2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria: NA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ANNABEL NA BLASI, PMPHD	Hospital Clinic of Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic		Barcelona		08037	Spain
Hospitla Clinic

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

PUBLICATION

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided