We will study the effects of the proteins of the contact activation system in thrombus formation, embolization and degradation in several coagulation assays.
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
Our main study endpoint is the ex vivo formation of thrombi in several
coagulation assays. We hypothesize that thrombi formed from blood of patients
deficient in FXII or FXI are less stable than those formed from blood from
controls.
Secondary outcome
not applicable
Background summary
Cardiovascular diseases are important causes of morbidity and mortality in the
industrialized world. Clinical studies indicate an important role for the
proteins of the contact activation system (coagulation factor XII (FXII), FXI,
prekallikrein and high molecular weight kininogen (HMWK)) on the risk of
cardiovascular disease. There is substantial evidence from mouse studies that
FXII and FXI participate in the formation and stability of thrombi and in vitro
studies showed that collagen is able to activate FXII and hereby stimulate
thrombin formation and potentiate the formation of platelet-fibrin thrombi. We
want to determine the role of the proteins of the contact activation system in
platelet mediated thrombus formation in human blood.
Study objective
We will study the effects of the proteins of the contact activation system in
thrombus formation, embolization and degradation in several coagulation assays.
Study design
Blood will be collected from human volunteers via a venipuncture in the
forearm. Each volunteer will donate maximally four times 30 ml of blood over a
period of two days. This blood is used incoagulation assays. We need fresh
whole blood because platelets are viable for four hours. After this time, new
blood is needed.
Study burden and risks
Blood will be drawn via a venipuncture in the forearm, maximally four times
during two days. Blood collection takes place at the academic hospital in
Maastricht. Each venipuncture is associated with a bleeding risk at the site of
puncture. FXI deficiency is associated with a mild bleeding tendency, however
the risk of bleeding after venipuncture is minimal. Deficiency in FXII,
prekallikrein or HMWK is not associated with a bleeding diathesis and therefore
the bleeding risk is equal to the risk in the control population.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
• Age: >= 18 years
• Deficiency in coagulation factor XII, coagulation factor XI, prekallikrein or high molecular weight kininogen (patients)
Exclusion criteria
(Other) Coagulation defects
Symptoms of active disease
Use of anti-platelet drugs
Use of aspirin / ascal
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 |
|---|---|
| ClinicalTrials.gov | NCT01114074 |
| CCMO | NL31014.068.10 |