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

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.

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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

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

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)

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.

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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

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

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 identifier (NCT number): NCT03484065

  Hide Study Locations
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United States, California
Children's Hospital of Orange Count
Orange, California, United States, 92868
United States, New York
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11040
Béni Messous
Algier, Algeria
University of Calgary
Calgary, Canada
Cairo University Pediatric Hospital
Cairo, Egypt
Chru Lille
Lille, France
Universitats Kilinikum Frankfurt
Frankfurt, Germany
Dr von Haumer Children's Hospital
Munich, Germany
St John Medical College Hospital
Bangalore, India
All India Institute of Medical Sciences
New Delhi, India
Sapienza Università di Roma
Roma, Italy
University School of Medicine
Hamamatsu, Japan
Kuwait University
Kuwait, Kuwait
Hotel Dieu-de-France
Beirut, Lebanon
St George Hospital
Beirut, Lebanon
Hopital d'Enfants de Rabat
Rabat, Morocco
Radboud University Medical Centre
Nijmegen, Netherlands
National Institute Of Blood Disease and Bone Marrow Transplantation
Karachi, Pakistan
Institute of Hematology and Transfusion Medicine
Warsaw, Poland
University Clinical Center
Belgrade, Serbia
National Centre of Hemostasis and Thrombosis
Martin, Slovakia
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Bern, Switzerland
University Hospitals of Geneva
Geneva, Switzerland
Hopital d'Enfants Bechir Hamza
Tunis, Tunisia
Uludag University
Bursa, Turkey
Cerrahpasa Faculty of Medicine
Istanbul, Turkey
Erciyes University
Kayseri, Turkey
Sponsors and Collaborators
University Hospital, Geneva
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Principal Investigator: Alessandro Casini, MD University Hospitals of Geneva

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Responsible Party: Casini Alessandro, MD, University Hospital, Geneva Identifier: NCT03484065     History of Changes
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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Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn