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Quality of Life in Patients With Congenital Afibrinogenemia (QualyAFIB)

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: NCT03484065
Recruitment Status : Active, not recruiting
First Posted : March 30, 2018
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Casini Alessandro, University Hospital, Geneva

Study Description
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Brief Summary:
The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.

Condition or disease Intervention/treatment
Afibrinogenemia, Congenital Other: Questionnaire quality of life

Detailed Description:
In this observational study, children and adults suffering from congenital afibrinogenemia confirmed by biology will be enrolled. All patients will receive a questionnaire on quality of life in their own language during a routine visit and filled out by the patient at home. A general questionnaire will be filled out by the patient's physician.
Study Design
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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Quality of Life in Patients With Congenital Afibrinogenemia
Actual Study Start Date : June 2016
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Afibrinogenemia Other: Questionnaire quality of life


Outcome Measures
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Primary Outcome Measures :
  1. The influence of the afibrinogenemia on the patients' quality of life assessed by the Haemo-QoL SF questionnaire (for children) and the Haem-A-QoL questionnaire (for adult) [ Time Frame: At inclusion ]

    The quality of life questionnaire includes item assessing:

    • Physical health
    • Feeling
    • View
    • Family
    • Friends
    • Others
    • Sport and school
    • Treatment
    • Perceived support
    • Dealing
    • Future
    • Relationship


Secondary Outcome Measures :
  1. Impact of the afibrinogenemic patient's clinical phenotype on the patients' quality of life [ Time Frame: At Inclusion ]

    The clinical phenotype will be assessed by a general questionnaire including data on:

    • Bleeding events
    • Bleeding events treatment
    • Thrombotic events
    • Thrombotic events treatment
    • Fibrinogen replacement (type of product and modality of replacement)


Eligibility Criteria
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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from congenital afibrinogenemia
Criteria

Inclusion Criteria:

  • Congenital afibrinogenemia confirmed by biology (absence of circulating fibrinogen) and genotype

Exclusion Criteria:

  • Lack of participant's consent
  • Patient unable to understand the questionnaire
Contacts and Locations
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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): NCT03484065


Locations
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Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Alessandro Casini, MD University Hospitals of Geneva
More Information
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Responsible Party: Casini Alessandro, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03484065    
Other Study ID Numbers: 2016-00447
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Casini Alessandro, University Hospital, Geneva:
Congenital fibrinogen disorders
Additional relevant MeSH terms:
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Afibrinogenemia
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn