The goal is to investigate wether a PNH clone could be the cause of an unexplained thrombosis. In the population of patients with unexplained thrombosis a PNH clone may be the cause.The goal is to investigate whether the prevalence of PNH clones is…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the prevalence of PNH clones within the selected population .
Secondary outcome
Not applicable
Background summary
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired genetic disorder of
the hematopoietic stem cell. The disorder is characterized by intravascular
hemolysis with hemoglobinuria and thrombosis which can be life threatening.
Several studies have shown that approximately 1.4 % of patients with venous or
arterial thrombosis with unexplained cause have a PNH clone. This PNH clone may
have been the cause of a first thrombotic event.
The clinical chemistry laboratory of the Treant Zorggroep location Scheper has
the possibility to detect small PNH clones by flow cytometry.
Study objective
The goal is to investigate wether a PNH clone could be the cause of an
unexplained thrombosis. In the population of patients with unexplained
thrombosis a PNH clone may be the cause.
The goal is to investigate whether the prevalence of PNH clones is described
correctly in literature.
Study design
All patients with unknown cause of thrombosis from the patients database of the
thrombosis service from Treant zorggroep, hospital location Scheper will be
selected.
After obtaining written consent, one extra tube of blood (4 mL) is collected
during a regular venapuncture. In this blood sample, the presence or absence of
a PNH clone is determined.
Name and address data, date of birth, diagnosis and the outcome of the
investigation is stored encrypted for all patients.
There is no control group.
The investigation relates to disease(s) from the classes vascular disorders.
The planned start date is September 1, 2016. The estimated completion date is
June 30, 2016 .
Study burden and risks
One extra tube of blood will be withdrawn during regular blood sampling. The
burden is therefore nihil. The risk of a venapuncture is negligible.
Boermarkeweg 60
Emmen 7824 AA
NL
Boermarkeweg 60
Emmen 7824 AA
NL
Listed location countries
Age
Inclusion criteria
Deep Vein Thrombosis
Recidive Deep Vein Thrombosis
Mesenterial Thrombosis
Pulmonary Embolism
Exclusion criteria
< 18 y and > 80 y
Incompetent
Known Cause of Thrombosis/Embolism
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 | NL56506.042.16 |