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

NCT04845555 | Unknown

• 1 other identifier: 002286
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemophilia A

Keywords

Hemophilia A; Clotting Factor Level; Exercise; Pharmacokinetics; Physical activity

Outcome Measures

Primary Outcomes (4)

• Type of physical activity documented in a digital template

  PwH are used to document the type and intensity of their physical activity in terms of a digital template which will be electronically requested monthly by co-workers of this study

  12 months

• Physiological parameters (heart rate of PwH, measured with FitBit Charge 4 HR)

  Individual type and intensity of physical activity measured as heart rate by an electronic activity wristband (Fitbit charge 4 HR, synchronized in corresponding FitBit Application) For the final evaluation, each physical activity will be clustered regarding type and intensity to differ between the specific demands of activity.

  12 months

• Total annual bleeding rate

  Number of bleedings per year, documented in a digital template

  12 months

• Clotting factor VIII level

  In percent, documented in "myPKFIT"

  12 months

Secondary Outcomes (7)

• Factor substitution in international units

  12 months

• Frequency of factor substitution

  12 months

• Score of subjective quality of life measured by the SF36 Health Survey

  Baseline, after 6 and 12 months

• Joint status in score points measured by Hemophilia Joint Health Score

  Baseline, after 6 and 12 months

• Pain status measured by the German Pain Questionnaire

  Baseline, after 6 and 12 months

Study Arms (1)

Patients with hemophilia A

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

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

Interventions

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

Patients with hemophilia A

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from hemophilia A recruited by cooperating hemophilic treatment centers.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prof. Dr. Dr. Thomas Hilberg: lead
• Takeda: collaborator
• University of Bonn: collaborator

Study Sites (1)

Department of Sports Medicine, University of Wuppertal

Wuppertal, North Rhine-Westphalia, 42117, Germany

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Hilberg, Prof.

  Head of Department of sports medicine Wuppertal

  STUDY CHAIR

Central Study Contacts

Thomas Hilberg, Prof.

CONTACT

0202-373-208-12; hilberg@uni-wuppertal.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Dr. phil.

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: April 15, 2021
• Study Start: September 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)