Quality of Life in Patients With Congenital Afibrinogenemia

Afibrinogenemia, Congenital Clinical Trial

— QualyAFIB  

Official title:

Quality of Life in Patients With Congenital Afibrinogenemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484065
• Other study ID #: 2016-00447
• Status: Completed
• Start date: June 2016
• Est. completion date: June 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Afibrinogenemia
• Afibrinogenemia, Congenital

Intervention

Other:
• Questionnaire quality of life

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Countries where clinical trial is conducted

United States,  Algeria,  Canada,  Egypt,  France,  Germany,  India,  Italy,  Japan,  Kuwait,  Lebanon,  Morocco,  Netherlands,  Pakistan,  Poland,  Serbia,  Slovakia,  Spain,  Switzerland,  Tunisia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	The quality of life questionnaire includes item assessing: Physical health; Feeling; View; Family; Friends; Others; Sport and school; Treatment; Perceived support; Dealing; Future; Relationship	At inclusion
Secondary	Impact of the afibrinogenemic patient's clinical phenotype on the patients' quality of life	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)	At Inclusion