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GUTDVT trial.


- candidate number9148
- NTR NumberNTR2790
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-feb-2011
- Secondary IDs08/312 METC AMC
- Public TitleGUTDVT trial.
- Scientific TitleBi-directional crosstalk between gut and endothelium in development of DVT via specific deficiencies in (vitamin K synthesizing) gram negative gut microbiota.
- ACRONYMGUTDVT
- hypothesiswe hypothesize that there is a link between gut microbiota composition and development of venous thrombosis.
- Healt Condition(s) or Problem(s) studiedDeep vein thrombosis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jun-2012
- Target number of participants20
- InterventionsAcenocoumarol in subjects with proven DVT according to current guidelines.
- Primary outcomeChanges 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 outcomeAssociations 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).
- Timepoints1. Baseline;
2. 3 monts after start acenocoumarol;
3. 2 months after cessation of acenocoumarol.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryDespite 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.
- Main changes (audit trail)
- RECORD21-feb-2011 - 13-mrt-2011


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