Evidence map›Paper›PMID 25079049›Full record

Trial reportInternational journal of stroke : official journal of the International Stroke Society2014

Outcomes following sonothrombolysis in severe acute ischemic stroke: subgroup analysis of the CLOTBUST trial.

Kristian Barlinn, Georgios Tsivgoulis, Andrew D Barreto, John Alleman, Carlos A Molina, Robert Mikulik, Maher Saqqur, Andrew M Demchuk, Peter D Schellinger, George Howard and 1 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in International journal of stroke : official journal of the International Stroke Society, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. High versus Low Mechanical Index Imaging Diagnostic Ultrasound in Patients with Myocardial Infarction: A Therapeutic Application Study.Medical science monitor : international medical journal of experimental and clinical research · 2020
    Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
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

11 authors.

Kristian BarlinnDresden University Stroke Center, Department of Neurology, University Hospital Carl Gustav Carus Dresden, Dresden, Germany.
Georgios Tsivgoulis
Andrew D Barreto
John Alleman
Carlos A Molina
Robert Mikulik
Maher Saqqur
Andrew M Demchuk
Peter D Schellinger
George Howard
Andrei V Alexandrov

Funding

University of Texas Specialized Program in Acute StrokeP50NS044227 · NINDS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI RAHBAR, MOHAMMAD HOSSEIN · 2002 to 2012
$17.9M
NINDS NIH HHS P50 NS044227
6 · The paper itself

Abstract

backgroundSonothrombolysis is safe and may increase the likelihood of early recanalization in acute ischemic stroke patients.

aimsIn preparation of a phase III clinical trial, we contrast the likelihood of achieving a sustained recanalization and functional independence in a post hoc subgroup analysis of patients randomized to transcranial Doppler monitoring plus intravenous tissue plasminogen activator (sonothrombolysis) compared with intravenous tissue plasminogen activator alone in the CLOTBUST trial.

methodsWe analyzed the data from all randomized acute ischemic stroke patients with pretreatment National Institutes of Health Stroke Scale scores ≥ 10 points and proximal intracranial occlusions in the CLOTBUST trial. We compared sustained complete recanalization rate (Thrombolysis in Brain Ischemia flow grades 4-5) and functional independence (modified Rankin Scale 0-1) at 90 days. Safety was evaluated by the rate of symptomatic intracranial hemorrhage within 72 h of stroke onset.

resultsOf 126 patients, a total of 85 acute ischemic stroke patients met our inclusion criteria: mean age 71 ± 11years, 56% men, median National Institutes of Health Stroke Scale 17 (interquartile range 14-20). Of these patients, 41 (48%) and 44 (52%) were randomized to intravenous tissue plasminogen activator alone and sonothrombolysis, respectively. More patients achieved sustained complete recanalization in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (38·6% vs. 17·1%; P = 0·032). Functional independence at 90 days was more frequently achieved in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (37·2% vs. 15·8%; P = 0·045). Symptomatic intracranial hemorrhage rate was similar in both groups (4·9% vs. 4·6%; P = 1·00).

conclusionsOur results point to a signal of efficacy and provide information to guide the subsequent phase III randomized trial of sonothrombolysis in patients with severe ischemic strokes.

Indexed as

Fibrinolytic AgentsStrokeTissue Plasminogen ActivatorTreatment OutcomeUltrasonography, Doppler, TranscranialAgedAged, 80 and overBrain IschemiaFemaleFollow-Up StudiesHumansMaleMiddle AgedFibrinolytic AgentsTissue Plasminogen Activatorclinical outcomeproximal occlusionsevere strokesonothrombolysis

Identifiers

PMID25079049
PMCPMC4227933

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.