Is it possible to detect prothrombotic states via the "calibrated automated thrombogram" in patients that endured CVST, who did no show deviations in the prothrombin time/activated partial thromboplastin time? Secondary, we will…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes of the calibrated automated thrombogram are: lag time, time to
peak, peak height, endogenous thrombin potential (area under the curve) and
peak reduction.
Secondary outcome
In addition, determinants which influence the coagulation cascade will be
measured (i.e.: PT, aPTT, Thrombintime, Fibrinogen, Prothrombin, Anti-thrombin,
Free tissue factor pathway inhibitor (TFPI), TFPI activity, Protein C, Free
Protein S, Total Protein S, vWF activity, vWF antigen, FVIII activity, FVIII
antigen, FV activity, FVII activity, FXI activity, FX activity, FXI activity,
FXII activity, FXIII activity, a2-antiplasmin, PAI-1 activity).
Background summary
The haemostatic thrombotic system (HTS) is a very diverse and complex system,
in which thrombin is the key player. One of the conditions in which the HTS is
altered, is cerebral venous sinus thrombosis (CVST); a relatively rare, but
potentially lethal condition. In approximately 15 per cent of these patients,
the cause of CVST remains unclear. Conventional clotting tests, such as
prothrombotic time and activated partial thromboplastin time, analyse the most
common aberrant factors of the coagulation cascade. Within these tests, it is
not possible to detect prothrombotic conditions nor to detect mild haemostatic
abnormalities. Therefore, there is need for a physiological function test that
can detect even minor aberrations. The calibrated automated thrombogram (CAT)
assay is a test which measures the process of thrombin generation as a whole
via fluorescence. By investigating the coagulation cascade in this manner, it
might be possible to detect even mild haemostatic disorders as well as the
prothrombotic state. This enables us to monitor patients with CVST who did not
show any aberration(s) in conventional clotting tests.
Study objective
Is it possible to detect prothrombotic states via the "calibrated automated
thrombogram" in patients that endured CVST, who did no show deviations in the
prothrombin time/activated partial thromboplastin time? Secondary, we will
investigate which molecular determinants of the thrombin generation curve are
affected in patients with CVST.
Study design
Pilot patient-study
Study burden and risks
Burden and risk associated with participation: All eligible subjects have to
make an appointment for antecubital venipuncture and to fill in the
questionnaire. The total research time is 30 minutes for one subject. The risks
for participants are small.
Benefit: Subjects do not directly benefit from positive results of the study.
Group relatedness: Group selection is based on the population of patients
admitted to Maastricht University Medical Centre (MUMC), who endured CVST in
the past three years. For both the study group as the control group no other
base population can be used.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria patient group:
Age above 18 years
Male and female
Radiologically proven sinus thrombosis in the past 3 years;Inclusion criteria control group:
*Inclusion criteria control group
Age above 18 years
Male and female
Exclusion criteria
Exclusion criteria patient group:
Patients with known coagulation disorders
Patients with a malignancy
Patients on hormonal contraception or who receive other hormonal therapy
Current use of oral anticoagulants
Incapacitated/ mentally disabled subjects;Exclusion criteria control group:
Known coagulation disorders
Subjects with known malignancy
Use of oral hormonal contraception or other hormonal therapy
Current use of oral anticoagulants
Incapacitated/disabled subjects*
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 | NL63775.068.17 |