Evidence map›Paper›PMID 29778325›Full record

Trial reportLancet (London, England)2018

Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial.

Nikola Sprigg, Katie Flaherty, Jason P Appleton, Rustam Al-Shahi Salman, Daniel Bereczki, Maia Beridze, Hanne Christensen, Alfonso Ciccone, Ronan Collins, Anna Czlonkowska and 19 more

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 225 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
225citing papers in PubMed, 23 pooled it
36.0field-weighted citation impact, top 1% 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.

NCT04200781 phase4unknown statusnot on this mapstarted 2019, after this paper: background citation

A Randomized, Controlled, Double-blind, Multi-center Clinical Study of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

TypeinterventionalSponsorShuGuang HospitalRan2019 to 2022Enrolled464ConditionsHemorrhagic StrokeArmsGranules of Shengdi Dahuang Decoction, Placebo
NCT04742205 phase2 / phase3completednot on this mapstarted 2021, after this paper: background citation

Effectiveness of Intravenous Tranexamic Acid in Primary Cerebral Hemorrhage for Prevention of Hematoma Progression: Protocol for a Randomized, Double Blind Placebo-controlled Trial

TypeinterventionalSponsorKathmandu Medical College and Teaching HospitalRan2021 to 2024Enrolled154ConditionsCerebral HemorrhageArmsTranexamic Acid 500 MG
NCT05713630 phase3recruitingnot on this mapstarted 2026, after this paper: background citation

TRACE STUDY: A Randomized Controlled Trial Using Tranexamic Acid in the Treatment of Subdural Hematoma

TypeinterventionalSponsorUnity Health TorontoRan2026 to 2030Enrolled130ConditionsSubdural HematomaArmsTranexamic acid (TXA), Placebo
NCT05836831 phase4recruitingnot on this mapstarted 2022, after this paper: background citation

Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

TypeinterventionalSponsorChristian Medical College and Hospital, Ludhiana, IndiaRan2022 to 2026Enrolled3,400ConditionsIntracerebral Hemorrhagic StrokeArmsTranexamic acid injection
3 · Its place in the literature

Who cites it

225 citing papers in PubMed, 23 syntheses or guidelines pooled it, 468 citations in OpenAlex.

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165 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 20 institutions in 12 countries.

Nikola SpriggStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, UK; Stroke, Nottingham University Hospitals NHS Trust, City Hospital Campus, Nottingham, UK. Electronic address: nikola.sprigg@nottingham.ac.uk.
Katie FlahertyStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, UK.
Jason P AppletonStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, UK.
Rustam Al-Shahi SalmanCentre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
Daniel BereczkiDepartment of Neurology, Semmelweis University, Budapest, Hungary.
Maia BeridzeThe First University Clinic of Tbilisi State Medical University, Tbilisi, Georgia.
Hanne ChristensenDepartment of Neurology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
Alfonso CicconeNeurology Unit, Azienda Socio Sanitaria Territoriale di Mantova, Mantua, Italy.
Ronan CollinsStroke Service, Adelaide and Meath Hospital, Tallaght, Ireland.
Anna Czlonkowska2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.
Robert A DineenRadiological Sciences, Division of Clinical Neuroscience, University of Nottingham, Queens Medical Centre Campus, Nottingham, UK; NIHR Nottingham Biomedical Research Centre, Nottingham, UK.
Lelia DuleyNottingham Clinical Trials Unit, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
Juan Jose Egea-GuerreroUGC de Medicina Intensiva, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla, Consejo Superior de Investigaciones Científicas, Universidad de Sevilla, Seville, Spain.
Timothy J EnglandVascular Medicine, Division of Medical Sciences and Graduate Entry Medicine, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.
Kailash KrishnanStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, UK; Stroke, Nottingham University Hospitals NHS Trust, City Hospital Campus, Nottingham, UK.
Ann Charlotte LaskaDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
Zhe Kang LawStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, UK; Stroke, Nottingham University Hospitals NHS Trust, City Hospital Campus, Nottingham, UK; Department of Medicine, National University of Malaysia, Kuala Lumpur, Malaysia.
Serefnur OzturkDepartment of Neurology, Selcuk University Medical Faculty, Konya, Turkey.
Stuart J PocockDepartment of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
Ian RobertsClinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.
Thompson G RobinsonDepartment of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.
Christine RoffeStroke Research, Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK.
David SeiffgeStroke Center, Neurology and Department of Clinical Research, University Hospital, University Basel, Basel, Switzerland.
Polly ScuttStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, UK.
Jegan ThanabalanDivision of Neurosurgery, Department of Surgery, National University of Malaysia, Kuala Lumpur, Malaysia.
David WerringStroke Research Centre, UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, University College London, London, UK.
David WhynesSchool of Economics, University of Nottingham, University Park, Nottingham, UK.
Philip M BathStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, UK; Stroke, Nottingham University Hospitals NHS Trust, City Hospital Campus, Nottingham, UK.
TICH-2 Investigators
University of Nottingham · GBLondon School of Hygiene & Tropical Medicine · GBNational University of Malaysia · MYNottingham City Hospital · GBNottingham University Hospitals NHS Trust · GBAzienda Socio Sanitaria Territoriale Lariana · ITHospital Universitario Virgen del Rocío · ESInstitute of Psychiatry and Neurology · PLKarolinska Institutet · SEKeele University · GBNational Hospital for Neurology and Neurosurgery · GBNIHR Leicester Biomedical Research Centre · GBNottingham Biomedical Research Centre · GBQueen's Medical Centre · GBSelçuk University · TRSemmelweis University · HUTallaght University Hospital · IETbilisi State Medical University · GEUniversity Hospital of Basel · CHUniversity of Copenhagen · DK

Funding

British Heart Foundation PG/14/50/30891British Heart Foundation SP/12/2/29422Department of Health 11/129/109Medical Research Council MR/M009211/1
6 · The paper itself

Abstract

backgroundTranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage.

methodsWe did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset. Randomisation was done centrally in real time via a secure website, with stratification by country and minimisation on key prognostic factors. Treatment allocation was concealed from patients, outcome assessors, and all other health-care workers involved in the trial. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale, using ordinal logistic regression with adjustment for stratification and minimisation criteria. All analyses were done on an intention-to-treat basis. This trial is registered with the ISRCTN registry, number ISRCTN93732214.

findingsWe recruited 2325 participants between March 1, 2013, and Sept 30, 2017. 1161 patients received tranexamic acid and 1164 received placebo; the treatment groups were well balanced at baseline. The primary outcome was assessed for 2307 (99%) participants. The primary outcome, functional status at day 90, did not differ significantly between the groups (adjusted odds ratio [aOR] 0·88, 95% CI 0·76-1·03, p=0·11). Although there were fewer deaths by day 7 in the tranexamic acid group (101 [9%] deaths in the tranexamic acid group vs 123 [11%] deaths in the placebo group; aOR 0·73, 0·53-0·99, p=0·0406), there was no difference in case fatality at 90 days (250 [22%] vs 249 [21%]; adjusted hazard ratio 0·92, 95% CI 0·77-1·10, p=0·37). Fewer patients had serious adverse events after tranexamic acid than after placebo by days 2 (379 [33%] patients vs 417 [36%] patients), 7 (456 [39%] vs 497 [43%]), and 90 (521 [45%] vs 556 [48%]).

interpretationFunctional status 90 days after intracerebral haemorrhage did not differ significantly between patients who received tranexamic acid and those who received placebo, despite a reduction in early deaths and serious adverse events. Larger randomised trials are needed to confirm or refute a clinically significant treatment effect.

fundingNational Institute of Health Research Health Technology Assessment Programme and Swiss Heart Foundation.

Indexed as

Acute DiseaseAdultAgedAged, 80 and overAntifibrinolytic AgentsCerebral HemorrhageDouble-Blind MethodFemaleHumansMaleMiddle AgedStrokeTranexamic AcidTreatment OutcomeYoung AdultAntifibrinolytic AgentsTranexamic Acid

Identifiers

PMID29778325
PMCPMC5976950
OpenAlexW2804714053

What OpenQuestion holds

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LicenceCC BY
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.