Evidence map›Paper›PMID 32611728›Full record

Observational studyStroke and vascular neurology2020

Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis.

Yi Dong, Ye Han, Haipeng Shen, Yilong Wang, Frank Ma, Hao Li, Yongjun Wang, Qiang Dong

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in Stroke and vascular neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02735226 (Shanghai Stroke Service System), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 13% of its field
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.

NCT02735226 unknown statusnot on this map

Shanghai Stroke Service System

Typeobservational_patient_registrySponsorShanghai Stroke Service SystemRan2014 to 2018Enrolled100,000ConditionsStrokeArmsstroke network and policy intervention
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

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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 at 5 institutions in 3 countries.

Yi DongDepartment of Neurology, Huashan Hospital Fudan University, Shanghai, Shanghai, China.ORCID 0000-0001-6630-112X
Ye HanDepartment of Business Administration, College of Business, University of Illinois at Urbana-Champaign, Champaign, Illinois, USA.
Haipeng ShenFaculty of Business and Economics, University of Hong Kong, Hong Kong, China.
Yilong Wang *Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China dong_qiang@fudan.edu.cn yilong528@aliyun.com.
Frank MaMedical Research Center, DotHealth, Shanghai, China.
Hao LiBig data and AI dempartment, China National Clinical Research Center for Neurological Diseases, Beijing, China.
Yongjun WangDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-9976-2341
Qiang Dong *Department of Neurology, Huashan Hospital Fudan University, Shanghai, Shanghai, China dong_qiang@fudan.edu.cn yilong528@aliyun.com.ORCID 0000-0002-3874-0130
Capital Medical University · CNFudan University · CNNational Clinical Research Center for Digestive Diseases · CNUniversity of Hong Kong · HKUniversity of Illinois Urbana-Champaign · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe risk of symptomatic intracranial haemorrhage (sICH) after thrombolysis is low but severe. Lower dose of alteplase may reduce the risk of sICH. We aim to identify subsets of patients who could benefit from lower dose of alteplase compared with standard dose.

methodsData from two observational registries were pooled together. A total of 3479 patients who had acute ischaemic stroke were entered into the interaction tree model. The response variable was the rate of sICH per the definition of the National Institute of Neurological Disorders and Stroke Study. Clinical improvement was measured by the National Institutes of Health Stroke Scale (NIHSS) and defined as NIHSS 0 or 1 or an improvement of more than 4 points (within 7 days or at discharge). Rare event logistic regression was performed to analyse the OR of safety outcome.

resultsTo optimise the interaction effect between tissue plasminogen activator (tPA) dosage (standard/lower) and patient subgroups, three subgroups based on the severity of stroke were identified: (1) NIHSS ≤4, (2) NIHSS between 5 and 14, and (3) NIHSS ≥15. The estimated difference of OR of having sICH was 2.71 (95% CI 0.80 to 7.69, p=0.10) for mild, 0.13 (95% CI 0.02 to 0.68, p=0.01) for moderate, and 0.65 (95% CI 0.19 to 2.55, p=0.52) for severe, respectively. In addition, patients who had moderate stroke treated with lower dose had comparable efficacy outcome (OR 1.23, 95% CI 0.71 to 2.13, p=0.45).

conclusionOur analysis demonstrated that in patients who had moderate stroke, lower doses of alteplase are associated with significant sICH reduction and non-inferior performance in efficacy, compared with those in the standard dose group. TRIAL REGISTRATION NUMBER: The TIMS-China was a national prospective stroke registry on thrombolytic therapy using intravenous tPA in patients who had acute ischaemic stroke. The results were initially published in 2012 without a clinical trial registration number. The Shanghai Stroke Service System was registered at www.clinicaltrial.gov (NCT02735226).

Indexed as

Thrombolytic TherapyAgedClinical Decision-MakingCluster AnalysisFemaleFibrinolytic AgentsFunctional StatusHumansInfusions, IntravenousIntracranial HemorrhagesIschemic StrokeMaleMiddle AgedRecovery of FunctionRegistriesRetrospective StudiesFibrinolytic AgentsTissue Plasminogen Activatorstrokethrombolysis

Identifiers

PMID32611728
PMCPMC7804063
OpenAlexW3039341841

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

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.