congenital bleedingdisorder Hemophilia A
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers: Age between 20between 20 to 70 years old (equally distributed over the age range) - 7 volunteers 20-40 years old - 7 volunteers 40-60 years old - 6 volunteers 60+ years old Hemophilia A patients: Diagnosed with mild (FVIII activity levels 5-40%), moderate (FVIII activity levels 1-5%) or severe hemophilia A (FVIII activity levels
Exclusion criteria
Exclusion criteria: A healthy volunteer who meets any of the following criteria will be excluded from participation in this study: use of anticoagulants or platelet antagonists (aspirin or any TAR); known allergy to stainless steel; trauma or surgery within the last two weeks; pregnancy; use of: - NSAIDs; - antimicrobial medication; - thyroid inhibitors; or SSRI*s. A hemophilia A patient who meets any of the following criteria will be excluded from participation in this study: use of anticoagulants or platelet antagonists (aspirin or any TAR); known allergy to stainless steel; trauma or surgery within the last two weeks; a bleeding episode within the last two weeks; clinical indication of liver cirrhosis (echographic indication, enlarged spleen, decreased platelet count); pregnancy; acquired FVIII inhibitors; use of: - NSAIDs; - antimicrobial medication; - thyroid inhibitors or SSRI*s; - Emicizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate that the EnzySystem HemA version A can record TG and quantitative FVIII activity levels within a time frame of 60 min in fresh blood samples of healthy volunteers and patients with hemophilia A. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are composed whether the measured values comply with the desired assay specificity and accuracy. Outcomes are analysed for equivalence compared to one-stage FVIII assay, FVIII chromogenic assay, thrombin generation via the Nijmegen Hemostasis Assay, and possibly via the Technoclone assay. Is it possible to measure FVIII activity with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with; - Precision in the normal range (60-140%): min. 30% - Precision in the low range (3-10%): min. 50% - Limit of Detection range min. 100 % FVIII activity - Limit of Detection low range min. 3 % FVIII activity Is it possible to measure TG with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with; - Precision in the normal range (60-140%) of control samples: min. 30% - Precision in patient with hemophilia A: min. 50% - Limit of Detection, high range > 400 nM thrombin activity - Limit of Detection measured with Plasma, low range | — |
Countries
Netherlands
Outcome results
None listed