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Scandinavian trial ...
Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial
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- Rudolph, Claudina (författare)
- Aarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark.
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- Rikken Lindberg, Beate (författare)
- Natl Hosp Norway, Oslo Univ Hosp, Dept Cardiothorac Surg, Oslo, Norway.
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- Resch, Timothy (författare)
- Rigshosp, Dept Vasc Surg, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Copenhagen, Denmark.
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- Mani, Kevin, 1975- (författare)
- Uppsala universitet,Kärlkirurgi
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- Björkman, Patrick (författare)
- Helsinki Univ Hosp, Abdominal Ctr, Dept Vasc Surg, Helsinki, Finland.
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- Laxdal, Elín Hanna (författare)
- Landspitali Univ Hosp, Dept Vasc Surg, Reykjavik, Iceland.
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- Støvring, Henrik (författare)
- Aarhus Univ, Dept Publ Hlth, Aarhus, Denmark.
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- Beck, Henriette Margrethe (författare)
- Aarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark.
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- Eriksson, Gunnar (författare)
- Aarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark.
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- Budtz-Lilly, Jacob (författare)
- Aarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark.
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Aarhus Univ Hosp, Dept Cardiovasc Surg, Div Vasc Surg, Aarhus, Denmark Natl Hosp Norway, Oslo Univ Hosp, Dept Cardiothorac Surg, Oslo, Norway. (creator_code:org_t)
- 2023-03-23
- 2023
- Engelska.
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Ingår i: Trials. - : BioMed Central (BMC). - 1745-6215. ; 24:1
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- BackgroundContemporary management of uncomplicated type B aortic dissections (uTBAD) is based on the acuity and various morphological features. Medical therapy is mandatory, while the risks of early thoracic endovascular aortic repair (TEVAR) are balanced against the potential for rupture, complex surgery, and death. Improved aortic morphology following TEVAR is documented, but evidence for improved overall survival is lacking. The costs and impact on quality of life are also needed.MethodsThe trial is a randomized, open-label, superiority clinical trial with parallel assignment of subjects at 23 clinical sites in Denmark, Norway, Sweden, Finland, and Iceland. Eligibility includes patients aged ≥ 18 with uTBAD of < 4 weeks duration. Recruited subjects will be randomized to either standard medical therapy (SMT) or SMT + TEVAR, where TEVAR must be performed between 2–12 weeks from the onset of symptoms.DiscussionThis trial will evaluate the primary question of whether early TEVAR improves survival at 5 years among uTBAD patients. Moreover, the costs and the impact on quality of life should provide sorely needed data on other factors that play a role in treatment strategy decisions. The common Nordic healthcare model, with inclusion of all aortic centers, provides a favorable setting for carrying out this trial, while the robust healthcare registries ensure data validity.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
Nyckelord
- Aneurysm
- Dissecting
- TEVAR
- Type B
- Stent graft
- Uncomplicated
- Aortic dissection
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Trials
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Rudolph, Claudin ...
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Rikken Lindberg, ...
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Resch, Timothy
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Mani, Kevin, 197 ...
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Björkman, Patric ...
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Laxdal, Elín Han ...
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Støvring, Henrik
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Beck, Henriette ...
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Eriksson, Gunnar
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Budtz-Lilly, Jac ...
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