NCT05503498

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 11, 2022

Last Update Submit

August 12, 2022

Conditions

Fibrinogen; Deficiency, AcquiredPHARMACOKINETICS

Outcome Measures

Primary Outcomes (1)

  • plasma fibrinogen level

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

    JUNE 2021- AUGUST 2022

Study Arms (1)

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

DATA RECORDINGOTHER

RECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION

AFIBRINOGENEMIA, CIRRHOSIS, TRAUMATICS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clinic

Barcelona, 08037, Spain

Location

Hospitla Clinic

Barcelona, Spain

Location

Study Officials

  • ANNABEL NA BLASI, PMPHD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 16, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

August 1, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations

ES(2)