Impact of Acquired FXIII Deficiency on Morbidity and Mortality

Acquired Factor XIII Deficiency Disease Clinical Trial

Official title:

Impact of Acquired FXIII Deficiency on Morbidity and Mortality Among Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416594
• Other study ID #: FXIII
• Status: Completed
• Start date: September 10, 2019
• Est. completion date: May 18, 2020

Study information

• Verified date: June 2020
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational prospective study aiming to assess acquired FXIII deficiency implications in morbidity and mortality

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 18, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• FXIII levels < 70%

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acquired Factor XIII Deficiency Disease
• Deficiency Diseases
• Factor XIII Deficiency

Intervention

Other:
• Data collection
Only data collection

Locations

Country	Name	City	State
Spain	Gregorio Marañon Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Patricia Duque González

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years