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Het ontstaan van post trombotisch syndroom.


- candidate number10526
- NTR NumberNTR3141
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-nov-2011
- Secondary IDsNL38236.068.11 CCMO
- Public TitleHet ontstaan van post trombotisch syndroom.
- Scientific TitleRole of innate immunity and fibrinolysis in the development of post thrombotic syndrome: A case-control study.
- ACRONYMIf PTS
- hypothesisThe markers CRP, D-dimer, Il-6, MCP-1, IFN-alfa, TLR-9, TGF-beta, MMP-2 or MMP-9 measured at least 2 year after the acute event of DVT are associated with PTS.
- Healt Condition(s) or Problem(s) studiedDeep vein thrombosis , Postthrombotic syndrome
- Inclusion criteriaCases:
1. Minimum age 18 years;
2. Consenting;
3. Having had a DVT 2-10 years ago;
4. PTS according to the Villalta scale: Villalta score ≥5 on two or more consecutive visits that were at least 3 months apart or venous ulceration.

Controls:
1. Minimum age 18 years;
2. Consenting;
3. Having had a DVT 2-10 years ago;
4. No PTS, according to the Villalta scale: No Villalta score ≥5 on two or more consecutive visits that were at least 3 months apart and no venous ulceration.

Healthy controls:
1. Minimum age 18 years;
2. Consenting;
3. Never had a DVT during their life;
4. No venous insufficiency caused by other factors (CEAP<3).
- Exclusion criteriaPre-existent venous insufficiency (skin signs C3-C6 on CEAP score or requiring ECS therapy).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-dec-2011
- planned closingdate1-jun-2012
- Target number of participants90
- InterventionsN/A
- Primary outcomeThe primary outcome will be the difference in levels of plasma concentrations of markers in relation to the outcome PTS between patients with PTS and patients without PTS.
- Secondary outcome1. Dose-dependent relation between the level of markers and severity of PTS;
2. Plasma concentration of markers in healthy controls that never had a DVT, compared to patients that have had a DVT.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A.C. Bouman
- CONTACT for SCIENTIFIC QUERIESDrs. A.C. Bouman
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
European Union
- PublicationsN/A
- Brief summaryBackground:
Post thrombotic syndrome (PTS) is a chronic complication of deep venous thrombosis, associated with a decreased quality of life and at the same time posing a significant economic burden to society. Up until now the pathogenesis of PTS is not fully understood. Inflammation and fibrosis are thought to be the key players in the pathogenesis of this condition. Innate immunity may determine thrombus resolution and therefore influence the risk of PTS. Markers of inflammation, but also markers for fibrosis or fibrinolysis, may be of use to unravel the pathogenic processes involved in post thrombotic changes to the vessel wall. Finding associations between these markers and PTS can therefore help us to extend the knowledge on the pathogenesis of PTS.

Objective:
To investigate the role of innate immunity and fibrinolysis in developing PTS by studying the association between markers of immunity, fibrosis and fibrinolysis.

Study design:
Observational hypothesis generating study that is performed as a case-control study.

Study population:
The cases are a group of 30 patients who had a DVT 2-10 years ago and consequently developed PTS. The controls are a group of 30 patients who had a DVT 2-10 years ago, but did not develop PTS. The controls are matched on age, gender and BMI.
A second control group consists of healthy controls, 30 healthy people who have never had a DVT during their life. The patients will be recruited from the Maastricht University Medical Centre and the Flevohospital in Almere. As healthy controls partners, brothers, sisters, other relatives or friends of the patients will be asked.

Intervention:
The participants will be asked to visit the hospital once-only for 3 tubes of blood to be drawn.

Study parameters:
The plasma levels of a panel of markers in participants with PTS compared to participants without PTS.

Risks:
The risks for all subjects participating in this study are the risks of a normal venipuncture: hematoma or continued bleed at the place of puncture.
- Main changes (audit trail)
- RECORD14-nov-2011 - 21-nov-2011


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