Evidence map›Paper›PMID 21808985›Full record

Trial reportNeuroradiology2012

Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial.

Patrik Michel, George Ntaios, Marc Reichhart, Christian Schindler, Julien Bogousslavsky, Philip Maeder, Reto Meuli, Max Wintermark

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Neuroradiology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Recanalisation therapies for wake-up stroke.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Thrombolysis for acute ischaemic stroke.The Cochrane database of systematic reviews · 2014
    Pooled it
  6. Trial
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. What to do With Wake-Up Stroke.The Neurohospitalist · 2015
    Review
  16. Review
  17. Stroke treatment using intravenous and intra-arterial tissue plasminogen activator.Current treatment options in cardiovascular medicine · 2012
    Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Patrik MichelDepartment of Neurology Service, Center Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland. patrik.michel@chuv.ch
George Ntaios
Marc Reichhart
Christian Schindler
Julien Bogousslavsky
Philip Maeder
Reto Meuli
Max Wintermark

Funding

CTSA: K12 COMPONENTKL2RR024130 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$19.3M
NCRR NIH HHS KL2 RR024130
6 · The paper itself

Abstract

introductionPatients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset.

methodsPatients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria.

resultsAt baseline, there was a trend towards older age [69.5 (57-78) vs. 49 (44-78) years] in the thrombolysis group (n = 6) compared to placebo (n = 6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44-206) cm(3) in the treatment arm and 29 (8-105) cm(3) in the placebo arm.

conclusionsThis pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established.

Indexed as

Double-Blind MethodFeasibility StudiesFemaleFibrinolytic AgentsHumansInjections, IntravenousMalePerfusion ImagingPilot ProjectsPlacebo EffectRadiography, InterventionalStrokeThrombolytic TherapyTissue Plasminogen ActivatorTomography, X-Ray ComputedTreatment OutcomeFibrinolytic AgentsTissue Plasminogen Activator

Identifiers

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.