To identify the abnormalities in the coagulation system leading to VTE and other thrombotic complications and to determine the prevalence of subclinical and clinically manifest thrombophlebitis and/or DVT in a well-defined Dutch VM population.
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1.) Signs of superficial or deep vein thrombosis on compression ultrasonography
of the limbs; 2.) Measurement of blood coagulation parameters.
Secondary outcome
na
Background summary
Patients with venous malformations may have localized intravascular
coagulopathy (LIC), characterized by elevated D-dimer levels, and causing
(painful) thrombosis and palpable phlebolith formation. At the same time,
fibrin levels may be low, causing a higher bleeding risk. It is conceivable
that an activated coagulation state could lead to potential thrombotic
complications such as superficial or deep vein thrombosis, pulmonary embolism
(PE) or chronic thromboembolic pulmonary hypertension (CTEPH). Currently, the
prevalence of venous thromboembolism in patients with venous malformations is
unknown. A better insight in the frequency of thrombotic complications and
coagulation abnormalities may in the future help to select those patients who
need anticoagulant therapy, either in prophylactic or therapeutic dosages.
Study objective
To identify the abnormalities in the coagulation system leading to VTE and
other thrombotic complications and to determine the prevalence of subclinical
and clinically manifest thrombophlebitis and/or DVT in a well-defined Dutch VM
population.
Study design
Cross-sectional observational study.
Study burden and risks
This research aims no direct therapeutic effects for the participants. However,
the benefits are improved diagnostic possibilities and a better insight in the
pathophysiology and natural history. A better insight in the frequency of
thrombotic complications and coagulation abnormalities may in the future help
to select those patients who need anticoagulant therapy, either in prophylactic
or therapeutic dosages. We guarantee low risk assessment because the
investigations are very limited for patients and will be performed by
experienced investigators.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients aged * 12 years with a venous malformation.
Exclusion criteria
-Patients with a vascular malformation other than a pure venous malformation
-Patients who refuse informed consent.
-Vascular malformation with a maximum surface smaller than 4 cm2 with an estimated extent in depth less than 4 cm.
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 | NL27241.018.09 |