The primary objective of this study is to demonstrate that the EnzySystem HemA version A can record TG and quantify FVIII activity levels within a time frame of 60 min in fresh whole blood samples of healthy volunteers and patients with hemophilia A…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 < 50 nM thrombin
other study parameters
All samples will also be tested for other hemostasis specific parameters as
these parameters may affect a proper measurement of both FVIII activity and
Thrombin Generation. The following parameters will be measured in plasma
obtained from the whole blood vacutainers. Moreover, left over samples (plasma)
will eventually be used to develop other coagulation related parameters.
- von Willebrand Factor antigen levels
- von Willebrand Factor ristocetin activity levels
- Prothrombin Fragment 1+2 levels
- ADAMTS13 activity
- FVIII antigen levels
- blood group
Background summary
To measure blood clotting, blood is taken from a vein. This blood is processed
in the laboratory and then tested. A new device has been developed that
requires only a very small volume of blood (5-10 drops of blood) to perform the
laboratory tests. The long-term goal is that this device can be used by a
doctor or at home to quickly measure blood clotting. In this research we want
to compare this new system with the standard methods - measurement in the
laboratory - and evaluate whether the correct value is determined.
Study objective
The primary objective of this study is to demonstrate that the EnzySystem HemA
version A can record TG and quantify FVIII activity levels within a time frame
of 60 min in fresh whole blood samples of healthy volunteers and patients with
hemophilia A in the Enzyre laboratory (for healthy volunteers) and the
Radboudumc (for patients with hemophilia A).
Study design
This is a cross-sectional observational study.
All participants are asked to fill a questionnaire prior to blood collection.
The blood of healthy volunteers will be collected in an office of Enzyre BV,
the blood of patients will be collected in the Radboudumc. Blood collection, by
venepuncture, will be conducted by a Radboudumc research nurse or phycisian of
the research team in both locations.
In total, four blood tubes with citrate as anticoagulant will be drawn (a total
of around 11 mL).
Study burden and risks
We anticipate no risk or impact for the subjects and patients participating in
the study. The protocol only refers to blood collection.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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 <1%)
Medication
- On demand treatment
- Washout of medication of at least 24 hours after treatment with short half
life (SHL) replacement therapy
- Washout of medication of at least 72 hours after treatment with extended half
life (EHL) replacement therapy
Age 20-70 years old
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82879.091.22 |