Evaluation of clinical and functional parameters in patients with Hemophilia aged above 60 years

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00010176
• Date of registration: 12/06/2017
• Prospective Registration: Yes
• Primary sponsor: Goethe-Universität Frankfurt
• Public title: Evaluation of clinical and functional parameters in patients with Hemophilia aged above 60 years
• Scientific title: Evaluation of clinical and functional parameters in patients with Hemophilia aged above 60 years - Hem_in_elderly
• Date of first enrolment: 23/04/2018
• Target sample size: 200
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00010176
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Wolfgang Miesbach
• Affiliation: Hämophiliezentrum/Hämostaseologie

• Name: Wolfgang Miesbach
• Affiliation: Hämophiliezentrum/Hämostaseologie, Institut für Transfusionsmedizin, Medizinische Klinik II, Goethe Universitätsklinikum

Key inclusion & exclusion criteria

Inclusion criteria: ? aged older than 60 years
? confirmed diagnosis of hemophilia A or B
? informed consent signed
Exclusion criteria: ? younger than 60 years
? no confirmed diagnosis of hemophilia A or B
? no informed consent
? lack of comprehension of study documents


Age minimum: 60 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Hereditary factor VIII deficiency

Hereditary factor IX deficiency

Hemophilia
D66
D67

Intervention(s)

Group 1: Patients with inherited Hemophilia A or B aged older than 60 years will be asked for different clinical parameters at study start and annually for further 5 years. (bleeding frequency and bleeding pattern, substitution therapy status, co-morbidity and co-medication, hospitalization, level of care, death).
Additionally these validated questionnaires will be answered (German versions):
? Joint status (Hemophilia Joint Health Score, HJHS)
? Depression (Geriatric depressions scale questionnaire, GDS-15)
? Health-related quality of life: SF-36v2 (© QualityMetric Incorporated, USA, 2006)
? physical functionality: Haemophilia Activity List 2.0 2015
? Motility test by Tinetti (Balance & Gait)

Primary Outcome(s)

Bleeding rate and bleeding pattern in the preceding year
, duration and kind of Substitution therapy,
data collection by CRF at study start and annually

Secondary Outcome(s)

Interaction of clinical, emotional and functional parameters as well as influence of age, Co-morbidities and medication;
Annual data collection by CRF and validated questionnaires (German Versions):

Clinical:
? Joint Condition (Hemophilia Joint Health Score, HJHS)
? Co-Morbidity and Co-Medication
? Cause and duration of hospitalization
? Level of care
? death/Cause of death

Emotional:
? Depression (Geriatric depressions scale questionnaire, GDS-15)
? Health-related quality of life: SF-36v2 (© QualityMetric Incorporated, USA, 2006)

Functional:
? physical functionality: Haemophilia Activity List 2.0 2015
? Tinetti Motility Test (Balance & Gait)

Comparison of Co-Morbidity with normal population (aggregated Data of RKI)

Source(s) of Monetary Support

Hämophiliezentrum, Institut für Transfusionsmedizin, Medizinische Klinik III, Goethe Universitätsklinikum

Ethics review

Status: Approved
Approval date: 27/04/2016
Contact:

[e-mail]

Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o Universitätsklinikum

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00010176#studyResults