No registrations found.
ID
Source
Brief title
Health condition
subject with suspected Deep Venous Thrombosis (DVT)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in fecal flora/gutmicrobiota (HITCHIP see Qin Nature 2010) analysis of 1200 known intestinal bacteria in subjects with DVT vs subjects with a clinical suspicion of DVT but the absence of this diagnosis.
Secondary outcome
Associations between gutmicrobiota changes (HITCHIP), plasma levels of coagulation (Endogenous thrombin potential) and endothelial gycocalyx metabolism (SDF sublingual imaging and plasma hyaluronan and heparansulphate by ELISA).
Background summary
Despite the fact that many risk factors for venous thromboembolism have been established, 50% of these patients still present with idiopathic thrombosis. It has also been shown that endothelial glycocalyx plays an important role in maintaining coagulation factors in plasma, however the pathophysiological effects has never been elucidated. Older literature indicated a role for gram negative gut bacteria on coagulation (crucial for synthesis of clotting factors II, VII, IX and X), yet the effect of the gut microbiota in relation to endothelial glycocalyx on thrombotic tone has never been studied. In this study we will investigate whether there is a link between gut bacteria composition and DVT and whether this is mediated via impaired endothelial glycocalyx.
Study objective
we hypothesize that there is a link between gut microbiota composition and development of venous thrombosis.
Study design
1. Baseline;
2. 3 monts after start acenocoumarol;
3. 2 months after cessation of acenocoumarol.
Intervention
Acenocoumarol in subjects with proven DVT according to current guidelines.
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Inclusion criteria
1. Males or postmenopausal females;
2. Age between 18 and 60 years;
3. Suspicion of DVT at time of inclusion;
4. Written informed consent for future evaluation at time of diagnosis;
5. Fasted (no meal, coffee or tea) for at least 3 hours.
Exclusion criteria
1. Smoking > 5 sig/day;
2. Premenopauzal females (due to hormonal changes);
3. Patients any medication including oral antionceptives and PPIs;
4. Use of antibiotics in last 3 months.
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 |
|---|---|
| NTR-new | NL2662 |
| NTR-old | NTR2790 |
| Other | METC AMC : 08/312 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |