Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Acquired FXIII Deficiency on Morbidity and Mortality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04416594
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Patricia Duque González, Hospital General Universitario Gregorio Marañon

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

Condition or disease Intervention/treatment
Acquired Factor XIII Deficiency Disease Other: Data collection

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Acquired FXIII Deficiency on Morbidity and Mortality Among Hospitalized Patients
Actual Study Start Date : September 10, 2019
Actual Primary Completion Date : February 12, 2020
Actual Study Completion Date : May 18, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medical and surgical hospitalized patients
Criteria

Inclusion Criteria:

  • FXIII levels < 70%

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416594


Locations
Layout table for location information
Spain
Gregorio Marañon Hospital
Madrid, Spain, 28007
Sponsors and Collaborators
Patricia Duque González
Layout table for additonal information
Responsible Party: Patricia Duque González, Principal Investigator, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT04416594    
Other Study ID Numbers: FXIII
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia Duque González, Hospital General Universitario Gregorio Marañon:
Factor XIII
Blood transfusion
Mortality
Additional relevant MeSH terms:
Layout table for MeSH terms
Factor XIII Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn