Research with human participants

Overview of medical research in the Netherlands

Patients with DVT on unusual places and/or < 45 years of age

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Last updated:

Frequency of PNH in a selection of patients with DVT. In several publications PNH has been described especially in patients with DVT and younger than 30 years of age and/or with DVT on unusual places.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Haemolyses and related conditions
Study type
Observational non invasive

ID

NL-OMON44902

Source

ToetsingOnline

Brief title

DVT patients with positive PNH

Condition

  • Haemolyses and related conditions
  • Embolism and thrombosis

Synonym

PNH

Research involving

Human

Sponsors and support

Primary sponsor :
Jeroen Bosch Ziekenhuis
Source(s) of monetary or material Support :
Alexion,Industrie betaald uitvoeren PNH testen. zie document kostenberekening.

Intervention

Keyword :
45 years, DVT, PNH, unusual places

Outcome measures

Primary outcome

Prevalence of PNH in this selected patient population

Secondary outcome

not applicable

Background summary

Frequency of PNH in a selection of patiente with DVT. In several publications
PNH has been described especially in patients with DVT and younger than 30
years of age and/or with DVT on unusual places. PNH could be an (additional)
cause of DVT. The objective of this study is to screen the population of DVT
patients as mentioned in order to determine the frequency of PNH in this group.
Only low percentages of PNH positive patients is expected. To screen this
population an extra tube blood has to be drawn in order to test for PNH by
flowcytometry.

Study objective

Frequency of PNH in a selection of patients with DVT. In several publications
PNH has been described especially in patients with DVT and younger than 30
years of age and/or with DVT on unusual places.

Study design

Selected patients will be asked to participate with the study and after signing
the informed consent .Blood will be drawn and tested by flowcytometry on
occurence PNH. All patient data will be coded by replacing the data with a
studynumber.

Study burden and risks

not applicable

Public
Jeroen Bosch Ziekenhuis

Henri Dunantsraat 1
's-Hertogenbosch 5223GZ
NL
Scientific
Jeroen Bosch Ziekenhuis

Henri Dunantsraat 1
's-Hertogenbosch 5223GZ
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

patients with DVT on unusual place and/or younger than 45 years (see also Protocol)

Exclusion criteria

patients with DVT on usual places and older than 45 years of age (see also Protocol)

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
500
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Brabant (Tilburg)

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 NL51971.028.15