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Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)

Eltoft, Agnethe (author)
Univ Hosp North Norway, Dept Neurol, Tromso, Norway.;UiT Arctic Univ Norway, Dept Clin Med, Tromso, Norway.
Wilsgaard, Tom (author)
UiT Arctic Univ Norway, Dept Community Med, Tromso, Norway.
Roaldsen, Melinda B. (author)
UiT Arctic Univ Norway, Dept Clin Med, Tromso, Norway.;Univ Hosp North Norway, Dept Clin Res, Tromso, Norway.
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Soyland, Mary-Helen (author)
UiT Arctic Univ Norway, Dept Clin Med, Tromso, Norway.;Sorlandet Hosp Kristiansand, Dept Neurol, Kristiansand, Norway.
Lundström, Erik, 1964- (author)
Uppsala universitet,Neurologi
Petersson, Jesper (author)
Skane Univ Hosp, Dept Neurol, Malmö, Sweden.
Indredavik, Bent (author)
Trondheim Reg & Univ Hosp, St Olavs Hosp, Dept Med, Trondheim, Norway.;Norwegian Univ Sci & Technol, Dept Neuromed & Movement Sci, Trondheim, Norway.
Putaala, Jukka (author)
Helsinki Univ Hosp, Dept Neurol, Helsinki, Finland.;Univ Helsinki, Helsinki, Finland.
Christensen, Hanne (author)
Bispebjerg Hosp, Dept Neurol, Copenhagen, Denmark.;Univ Copenhagen, Copenhagen, Denmark.
Korv, Janika (author)
Univ Tartu, Dept Neurol & Neurosurg, Tartu, Estonia.;Tartu Univ Hosp, Tartu, Estonia.
Jatuzis, Dalius (author)
Vilnius Univ, Dept Neurol & Neurosurg, Ctr Neurol, Vilnius, Lithuania.
Engelter, Stefan T. (author)
Univ Hosp Basel, Dept Neurol, Basel, Switzerland.;Univ Basel, Basel, Switzerland.;Univ Basel, Univ Dept Geriatr Med Felix Platter, Neurol & Neurorehabil, Basel, Switzerland.
De Marchis, Gian Marco (author)
Univ Hosp Basel, Dept Neurol, Basel, Switzerland.;Univ Basel, Basel, Switzerland.
Werring, David J. (author)
UCL Queen Sq Inst Neurol, Stroke Res Ctr, London, England.
Robinson, Thompson (author)
Univ Leicester, Coll Life Sci, Leicester, Leics, England.;Univ Leicester, NIHR Biomed Res Ctr, Leicester, Leics, England.
Tveiten, Arnstein (author)
Sorlandet Hosp Kristiansand, Dept Neurol, Kristiansand, Norway.
Mathiesen, Ellisiv B. (author)
Univ Hosp North Norway, Dept Neurol, Tromso, Norway.;UiT Arctic Univ Norway, Dept Clin Med, Tromso, Norway.
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Univ Hosp North Norway, Dept Neurol, Tromso, Norway;UiT Arctic Univ Norway, Dept Clin Med, Tromso, Norway. UiT Arctic Univ Norway, Dept Community Med, Tromso, Norway. (creator_code:org_t)
2022-05-19
2022
English.
In: Trials. - : Springer Nature. - 1745-6215. ; 23:1
Related links:
https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
https://urn.kb.se/re...
https://doi.org/10.1...
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Background: Patients with wake-up ischemic stroke are frequently excluded from thrombolytic treatment due to unknown symptom onset time and limited availability of advanced imaging modalities. The Tenecteplase in Wake-up lschaemic Stroke Trial (TWIST) is a randomized controlled trial of intravenous tenecteplase 0.25 mg/kg and standard care versus standard care alone (no thrombolysis) in patients who wake up with acute ischemic stroke and can be treated within 4.5 h of wakening based on non-contrast CT findings. Objective: To publish the detailed statistical analysis plan for TWIST prior to unblinding. Methods: The TWIST statistical analysis plan is consistent with the Consolidating Standard of Reporting Trials (CON-SORT) statement and provides clear and open reporting. Discussion: Publication of the statistical analysis plan serves to reduce potential trial reporting bias and clearly outlines the pre-specified analyses.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Neurologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Neurology (hsv//eng)

Keyword

Ischemic stroke
Thrombolysis
Wake-up stroke
Tenecteplase
TWIST
Acute stroke therapy

Publication and Content Type

ref (subject category)
art (subject category)

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