Fibrinogen; Deficiency, AcquiredPKMFNCT05503498
Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration
An observational study of Fibrinogen; Deficiency, Acquired and PHARMACOKINETICS, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial summary
characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fibrinogen; Deficiency, Acquired, PHARMACOKINETICS
- What is being tested?
- DATA RECORDING
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Population Pharmacokinetic Modeling of Fibrinogen in Patients With Congenital or Acquired -Chronic or Acute- Hypofibrinogenemia
characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.
Read the 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.
- Conditions
- Fibrinogen; Deficiency, Acquired, PHARMACOKINETICS
- Being tested
- DATA RECORDING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DATA RECORDINGOther
RECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: DATA RECORDING |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma fibrinogen level
to develop a pharmacokinetic model to predict the plasma fibrinogen level after fibrinogen administration
Measured: JUNE 2021- AUGUST 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrinogen; Deficiency, AcquiredStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Principal investigator, Annabel Blasi, Hospital Clinic of Barcelona
- Investigators
- ANNABEL NA BLASI, PMPHD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503498
- Sponsor's protocol ID
- PMODEL
- Acronym
- PKMF
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: PUBLICATION
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetic Modeling of Fibrinogen in Patients With Congenital or Acquired -Chronic or Acute- Hypofibrinogenemia
- ClinicalTrials.gov ID
- NCT05503498
- Acronym / sponsor ID
- PKMF / PMODEL
- Conditions
- Fibrinogen; Deficiency, Acquired, PHARMACOKINETICS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFIBRINOGENEMIA, CIRRHOSIS, TRAUMATICS | – | Other: DATA RECORDINGPATIENTS 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DATA RECORDINGRECORD PLASMA FIBRI LEVELS AFTER FIBRINOGEN ADMINISTRATION | Other | AFIBRINOGENEMIA, CIRRHOSIS, TRAUMATICS |
Primary outcome
plasma fibrinogen level
Time frame: JUNE 2021- AUGUST 2022
to develop a pharmacokinetic model to predict the plasma fibrinogen level after fibrinogen administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: Undecided. PUBLICATION
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RecruitingObservational study
Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
Trauma Induced Coagulopathy, Trauma Coagulopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANNABEL NA BLASI, PMPHD principal investigator
Hospital Clinic of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrinogen; Deficiency, Acquired and PHARMACOKINETICS, run by Hospital Clinic of Barcelona at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma fibrinogen level (time frame: JUNE 2021- AUGUST 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.