Before routinely starting collection of blood with these devices several objectives need to be addressed. A) Is there a difference in coagulation activation parameters between blood collected by venous phlebotomy, finger prick capillary blood and…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The following biomakers will be analyzed in the different samples.
A) Full length Tissue Factor antigen levels
B) Prothrombin F1+2
C) D-dimer
D) Factor VIII antigen and activity levels
Secondary outcome
Blood volume obtained
Time of collection
Reaction of skin and bruises etc.
Background summary
Blood collection is an important parameter in the determination of blood
coagulation. Normally, venous phlebotomy is required for standard analysis. For
point of care tests capillary blood is sufficient. Capillary blood can be
collected by a standard finger prick but might not be ideal as it is not
directly mixed with a proper anticoagulant. Seventh Sense Biosystems has
developed the TAP blood collection device able to collect a small volume of
capillary blood (100 µl) which is directly anticoagulated. This new system
might be an interesting collection device for our miniaturized thrombin
generation assay, an assay that is more sensitive than other currently
available coagulation point of care tests.
Study objective
Before routinely starting collection of blood with these devices several
objectives need to be addressed. A) Is there a difference in coagulation
activation parameters between blood collected by venous phlebotomy, finger
prick capillary blood and capillary blood collected with the TAP device. B)
Which anticoagulants is best to use?; C) is the composition of the measured
biomarkers the same in controls and patients with severe Hemophilia A?
Study design
We aim to collect blood of 50 adult volunteers and 10 adult patients with
hemophilia A. Blood of each donor will be collected by: finger prick (2
locations per donor, 1 for each anticoagulant, 2 drops per incision), one
venous puncture and at two upper arms blood collected with either the 7SBio
100 µl Li-Hep (TAP 100-C*) device or the same TAP device filled with another
anticoagulant. We aim to recruit hemophilia A patients within the Hemophilia
Treatment Center (HTC) Nijmegen-Eindhoven-Maastricht (NEM), preferably at
location Radboudumc.
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 by three different
methods.
Geert Grooteplein zuid 8
Nijmegen 6524 GA
NL
Geert Grooteplein zuid 8
Nijmegen 6524 GA
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for healthy subjects: 20 years or older, no known
(co)morbidities.
Inclusion criteria patients: To have severe hemophilia A and 20 years or older.
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)
- pregnancy
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)
- 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, enlarged liver, decreased platelet count)
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 | NL63677.091.17 |