Impact of Acquired FXIII Deficiency on Morbidity and Mortality

June 3, 2020 updated by: Patricia Duque González

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Gregorio Marañón Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medical and surgical hospitalized patients

Description

Inclusion Criteria:

  • FXIII levels < 70%

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Factor XIII deficiency
Patients admitted to hospital with FXIII levels below 70% during their hospital stay
Other: Data collection
Only data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patricia Duque González

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Actual)

February 12, 2020

Study Completion (Actual)

May 18, 2020

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FXIII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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