Acquired Factor XIII Deficiency DiseaseNCT04416594
Impact of Acquired FXIII Deficiency on Morbidity and Mortality
An observational study of Acquired Factor XIII Deficiency Disease, run by Patricia Duque González at 1 site in Spain.
Trial summary
Observational prospective study aiming to assess acquired FXIII deficiency implications in morbidity and mortality Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Factor XIII Deficiency Disease
- What is being tested?
- Data collection
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 10 Sep 2019to 18 May 2020
- 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: Medical and surgical hospitalized patients
Who may be able to join
- FXIII levels < 70%
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Acquired FXIII Deficiency on Morbidity and Mortality Among Hospitalized Patients
Observational prospective study aiming to assess acquired FXIII deficiency implications in morbidity and mortality
Read the detailed description
All patients admitted to a large tertiary hospital with FXIII levels below 70% during their hospital stay are assessed. Data regarding patient background, blood transfusion, morbidity and mortality is registered.
- Conditions
- Acquired Factor XIII Deficiency Disease
- Being tested
- Data collection
- Keywords
- Factor XIII, Blood transfusion, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Only data collection
| Study group | Role | What they receive |
|---|---|---|
| Factor XIII deficiency | Patients admitted to hospital with FXIII levels below 70% during their hospital stay Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut-Point levels of FXIII
The investigators aim to find a laboratory parameter, a cut-point plasma level of FXIII, to identify an increased in morbidity and mortality in a mixed cohort of hospitalized patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start10 Sep 2019
- Primary completion12 Feb 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acquired Factor XIII Deficiency DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patricia Duque González
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patricia Duque González, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416594
- Sponsor's protocol ID
- FXIII
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Duque P, Esteban ML, Pineiro P, Ortiz-Lopez A, Moreno-Carbonell M, Lancho P, Calvo A, Terradillos E, Pascual-Izquierdo C. Acquired factor XIII deficiency is associated with mortality and is not linked to hypocalcemia. Blood Coagul Fibrinolysis. 2026 Jan 1;37(1):28-37. doi: 10.1097/MBC.0000000000001400. Epub 2025 Nov 27.
PubMed 41311329Duque P, Chasco-Ganuza M, Ortuzar A, Almaraz C, Terradillos E, Perez-Rus G, Pascual C. Acquired FXIII Deficiency is Associated with High Morbidity. Thromb Haemost. 2022 Jan;122(1):48-56. doi: 10.1055/a-1481-2733. Epub 2021 Jun 6.
PubMed 33851388
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acquired FXIII Deficiency on Morbidity and Mortality Among Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04416594
- Acronym / sponsor ID
- FXIII
- Conditions
- Acquired Factor XIII Deficiency Disease
- Keywords
- Factor XIII, Blood transfusion, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Patricia Duque GonzálezUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 4 Jun 2020 (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.
Observational prospective study aiming to assess acquired FXIII deficiency implications in morbidity and mortality
Detailed description
All patients admitted to a large tertiary hospital with FXIII levels below 70% during their hospital stay are assessed. Data regarding patient background, blood transfusion, morbidity and mortality is registered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Factor XIII deficiency | – | Other: Data collectionPatients admitted to hospital with FXIII levels below 70% during their hospital stay |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medical and surgical hospitalized patients
Key inclusion criteria (1 listed)
- FXIII levels < 70%
Key exclusion criteria (1 listed)
- None
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 collectionOnly data collection | Other | Factor XIII deficiency |
Primary outcome
Cut-Point levels of FXIII
Time frame: 2 years
The investigators aim to find a laboratory parameter, a cut-point plasma level of FXIII, to identify an increased in morbidity and mortality in a mixed cohort of hospitalized patients
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 5 Jun 2020.
- Derived from this study: PubMed 41311329Duque P, Esteban ML, Pineiro P, Ortiz-Lopez A, Moreno-Carbonell M, Lancho P, Calvo A, Terradillos E, Pascual-Izquierdo C. Acquired factor XIII deficiency is associated with mortality and is not linked to hypocalcemia. Blood Coagul Fibrinolysis. 2026 Jan 1;37(1):28-37. doi: 10.1097/MBC.0000000000001400. Epub 2025 Nov 27.
- Derived from this study: PubMed 33851388Duque P, Chasco-Ganuza M, Ortuzar A, Almaraz C, Terradillos E, Perez-Rus G, Pascual C. Acquired FXIII Deficiency is Associated with High Morbidity. Thromb Haemost. 2022 Jan;122(1):48-56. doi: 10.1055/a-1481-2733. Epub 2021 Jun 6.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Factor XIII Deficiency Disease, run by Patricia Duque González at 1 site 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 1 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 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Cut-Point levels of FXIII (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416594, which also lists 2 linked publications.
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 5 Jun 2020.