To investigate inflammatory processes in (sub) acute DVT at a cellular level.
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcomes are correlations between quantified cell profiles in the thrombus and
blood leucocyte profiles of patients in relation to thrombus age and thrombus
resolution.
Secondary outcome
A MRI protocol will be optimised for imaging techniques to gather non-invasive
information about thrombus age and resolution.
Background summary
Information about local cellular processes involved in thrombus resolution in
humans following Deep Venous Thrombosis of the leg (DVT) is scarce. The
currently prevaling hypothesis is, that inflammation is an important process in
DVT both for thrombus resolution and for the development of post-thrombotic
syndrome.
Study objective
To investigate inflammatory processes in (sub) acute DVT at a cellular level.
Study design
Single centre observational mechanistic exploratory pilot study with one-time
invasive sampling
Study burden and risks
During the (sub) acute phase of DVT, in patients that will undergo a
thrombolysis thrombus material will be harvested and antecubital vena punction
for laboratory testing will be performed. Renal function will, if unknown, be
determined because of the use of contrast agent for MR examination. No
additional visits will be needed, no questionnaires or diaries need to be
filled out. Due to the venapunction patients may experience some discomfort and
they will be at a moderate risk for bleeding. No other risks are expected.
There is no group relatedness.
P. Debyelaan 25
Maastricht 6202 AZ
NL
P. Debyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
- Femoro-popliteal thrombosis, objectively confirmed
- Onset of complaints suggestive of DVT<6 weeks
- Informed consent (IC)
Exclusion criteria
- - < 18 years
- History of GI bleeding within 12 months
- History of CVA/CNS disease within 12 months
- Severe hypertension (>180/100mmHg)
- Pregnancy
- Previous DVT in the affected leg
- Previous deep venous surgery in the affected leg
- Previous interventions of the superficial venous system <12 months
- Known coagulation disorders
- Surgery within two weeks
- Active malignancy
- Diabetes
- Chronic inflammatory diseases or (auto) immune diseases
- Use of anti-inflammatory medication
- Use of statins
- Allergy to contrast agent (Gadovist)
- Contra-indications for MRI
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 | NL59253.068.17 |