Association Between Individual Clotting Factor Level Monitoring and the Risk of Bleeding Whilst Physical Active Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2022-12-30

Brief Summary

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The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically active

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Detailed Description

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In patients with haemophilia (PwH) repetitive joint bleedings result in a so called haemophilic arthropathy, which is often associated with chronic pain as well as functional restrictions.

Due to the opportunity of sufficient factor treatment regimes, physical activity is no longer considered as a risk factor for PwH. In contrast, the large amount of current scientific evidence demonstrated high benefits of regular exercising for PwH. Meanwhile, physical activity is integrated as recommendation in the ´Guidelines for the management of hemophilia´. Nevertheless, the detailed influence of the exact course of the individual clotting factor level corresponding to the intensity of physical activities in consideration of possible bleeding events in adult PwH have not been examined to date.

The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically activie. Hereby the focus is on haemophilic specific parameters such as bleeding events, factor treatment and pain. On the basis of this study, an individualized clotting factor level should be determined which ensures a minimized risk of a bleeding event, considering type and intensity of the exercises. In line with these new findings, further interventional studies could be initiated in order to safely enhance the degraded physical performance as well as quality of life in PwH.

The generated knowledge could be further used in the development of haemophilic specific recommendations regarding physical activity in consideration of the individual clotting factor level.

Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with hemophilia A

Patients suffering from moderate or severe hemophilia A (FVIII \<5%) over the age of 12 years.

Observation of the association between clotting factor level and risk of bleeding whilst physical activity

Intervention Type OTHER

The participants of this study will be monitored for a period of twelve months regarding individual clotting factor level, bleeding episodes as well as type and intensity of physical activity. By doing so, bleeding events, factor consumption as well as the course of the individual factor clotting factor level will be documented via the mobile application "myPKFiT". This individual factor treatment regime will be compared with the retrospective treatment outcome in the last twelve months before the first study visit.

Interventions

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Observation of the association between clotting factor level and risk of bleeding whilst physical activity

The participants of this study will be monitored for a period of twelve months regarding individual clotting factor level, bleeding episodes as well as type and intensity of physical activity. By doing so, bleeding events, factor consumption as well as the course of the individual factor clotting factor level will be documented via the mobile application "myPKFiT". This individual factor treatment regime will be compared with the retrospective treatment outcome in the last twelve months before the first study visit.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients suffering from moderate or severe hemophilia A (FVIII \<5%, ≥ 12 years old)
* factor treatment with ADVATE© or ADYNOVI©
* use of myPKFiT

Exclusion Criteria

* patients suffering from other coagulopathies
* participants without written consent
* participants \< 12 years old
* joint surgery like arthroscopy, synovectomy up to six months before study
* suffering from different rheumatologic diseases like M. Bechterew, Psoriasi or other local or generalized joint infections (Borreliosis, septic arthritis)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No