Evidence map›Paper›PMID 29895329›Full record

Trial reportBMC research notes2018

Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial.

Christian Ovesen, Janus Christian Jakobsen, Christian Gluud, Thorsten Steiner, Zhe Law, Katie Flaherty, Rob A Dineen, Philip M Bath, Nikola Sprigg, Hanne Christensen

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC research notes, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 20% 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.

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

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. 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

10 authors at 8 institutions in 4 countries.

Christian OvesenDepartment of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg bakke 23, 2400, Copenhagen, Denmark. Christian.aavang.ovesen@regionh.dk.
Janus Christian JakobsenThe Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Christian GluudThe Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Thorsten SteinerDepartment of Neurology, Klinikum Frankfurt Höchst, Frankfurt, Germany.
Zhe LawStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, NG5 1PB, UK.
Katie FlahertyStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, NG5 1PB, UK.
Rob A DineenRadiological Sciences, Division of Clinical Neuroscience, Queen's Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK.
Philip M BathStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, NG5 1PB, UK.
Nikola SpriggStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, NG5 1PB, UK.
Hanne ChristensenDepartment of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg bakke 23, 2400, Copenhagen, Denmark.
University of Nottingham · GBBispebjerg Hospital · DKCopenhagen University Hospital · DKHeidelberg University · DEHolbæk Sygehus · DKNottingham City Hospital · GBQueen's Medical Centre · GBRigshospitalet · DK

Funding

Department of Health 11/129/109National Institute for Health Research project number 11_129_109Velux Fonden grant no. 00012779
6 · The paper itself

Abstract

objectiveWe present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status.

resultsPrimary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).

Indexed as

Data Interpretation, StatisticalAntifibrinolytic AgentsCerebral HemorrhageDisease ProgressionHematomaHumansOutcome Assessment, Health CareTranexamic AcidAntifibrinolytic AgentsTranexamic AcidHaematoma expansionHaemostaticsIntracerebral haemorrhageSpot signTranexamic acid

Identifiers

PMID29895329
PMCPMC5998558
OpenAlexW2808366031

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.