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Antithrombotic stewardship


- candidate number20869
- NTR NumberNTR4887
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2014
- Secondary IDs 
- Public TitleAntithrombotic stewardship
- Scientific TitleAntithrombotic stewardship: a multidisciplinary team approach towards improving antithrombotic therapy during and after hospitalisation
- ACRONYM
- hypothesisThe Dutch HARM study into HARMs showed that antithrombotics belong to the top 5 of medication involved in potentially preventable HARMs. Our idea is that the implementation of a S-team in a hospital reduces the frequency of bleeding and thrombotic events.
- Healt Condition(s) or Problem(s) studiedAntitrombotics, New Oral Anticoagulants (NOAC), Low molecular weight heparin (LMWH)
- Inclusion criteriaIncluded will be patients on antithrombotics (unfractionated heparin (UFH), low-molecular weight heparin (LMWH), VKA or NOAC.
- Exclusion criterianone
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-sep-2018
- Target number of participants2000
- InterventionsThe intervention consists of the S-team, consisting of a specialized thrombosis nurse as casemanager, haematologist, medical leader Thrombosis Service, hospital pharmacist/clinical pharmacologist, cardiologist and a paediatric haematologist. During a 9 month period the S-team is active.
- Primary outcomeComposite endpoint: proportion of patients with equal or greater than 1 bleeding or equal or greater than 1 arterial/venous thrombotic events during and after hospitalization.
- Secondary outcomeEach of the components of the primary endpoint separately (bleeding, thrombosis), severity of bleeding complication, length of hospital stay, patient related outcomes (quality of life, belief in medicines questionnaire [8], adherence; patient satisfaction), healthcare costs (labour costs versus costs for bleeding/thrombotic events (including use of antidotes), and cost-effectiveness analysis.
- TimepointsDuring a 9 month period usual care is provided to patients. In this period the primary en secondary data will be collected.
The intervention (implementation of an S-team) will be implemented during a 3 month period. During a 9 month period the S-team is active. The same data are collected as during the pre-intervention measurement phase
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. P.M.L.A. Bemt, van den
- CONTACT for SCIENTIFIC QUERIESDr. P.M.L.A. Bemt, van den
- Sponsor/Initiator Reinier de Graaf Gasthuis, Delft
- Funding
(Source(s) of Monetary or Material Support)
DSW Health Insurance, Bayer, NL, Boehringer Ingelheim, Pfizer, Daiichi Sankyo
- Publications
- Brief summaryThe study is a two centre study with a pre- and post-intervention design and including almost 2000 patients. The intervention would be the implementation of a multidisciplinary antithrombotic team.
- Main changes (audit trail)
- RECORD3-nov-2014 - 22-nov-2015


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