Quality of Life in Patients With Congenital Afibrinogenemia

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.

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Key information

Conditions

Afibrinogenemia, Congenital Afibrinogenemia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Béni Messous, Algiers, Algeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire quality of life

Other

Primary outcomes

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Acronym: QualyAFIB

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2020
First posted: Mar 30, 2018
Registry last updated: Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed