TICH-2 MRI Sub-study
Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage 2 (TICH-2) trial MRI sub-study
Multicentre brain MRI (DWI, FLAIR, T2*-GRE, T1w, T2w, optional SWI) of 219 patients with acute spontaneous intracerebral haemorrhage in the TICH-2 tranexamic acid trial, with microbleed masks in a labelled subset of 115 SWI scans. Shared on written request to the sub-study PI.
Overview
The TICH-2 MRI sub-study added brain MRI to TICH-2, a double-blind, placebo-controlled phase 3 trial of intravenous tranexamic acid given within 8 hours of acute spontaneous intracerebral haemorrhage. It was run from the University of Nottingham, funded by the British Heart Foundation, and recruited from July 2015 to September 2017. Its main question was whether tranexamic acid increases small ischaemic lesions on diffusion-weighted imaging away from the haematoma. The sub-study data were later used to develop and test automated cerebral microbleed detection.
Composition
The results paper analysed 219 participants with usable MRI from 50 trial centres: 96 had received tranexamic acid and 123 placebo. 126 were men, and the mean age was 65.1 years (SD 13.8). A labelled subset of 115 participants with SWI was used for microbleed work; in that subset ages ranged from 29 to 88 years (mean 64.76, median 66.5) and 71 participants had microbleeds.
Acquisition
The protocol planned scans around day 5 (allowed day 2 to 14) and day 90 (day 83 to 110) after randomisation. The results paper analysed scans taken within two weeks. Required sequences were axial 2D DWI, T2-FLAIR, T2*-weighted GRE and T2-weighted imaging plus a sagittal 3D T1-weighted volume; manufacturer SWI (SWAN, VEN_BOLD or SWI) was optional because not every site had it. Preferred and acceptable parameter ranges were set per sequence, so slice thickness, matrix and resolution vary between sites.
Annotations
One investigator labelled microbleeds on T2*-weighted GRE or SWI as definite or possible using the Microbleed Anatomical Rating Scale (MARS). For 115 SWI scans, manual voxel segmentations exist for all 71 participants with microbleeds, 849 microbleeds in total when definite and possible ones are combined. The protocol planned semi-automated detection of remote DWI lesions, with each candidate accepted or rejected by expert readers.
Known limitations
- Not public. Access needs a written proposal to the sub-study PI and a Data Transfer Agreement whose terms are not published.
- Participants joined after randomisation, so survivors may be over-represented.
- Field strength, scanner vendors and countries of the MRI sites are not given in the main text of the papers.
- How many participants had SWI or a day 90 scan beyond the labelled subset is not published.
Cohort
Aggregate numbers from the sources below. Bars are relative to the 219 subjects.
Sex
- Male 126 100%
Covers 126 of 219 subjects.
Age
mean 65.1± 13.8No age bins reported.
Contrast / sequence
subjects, values can overlap
- Diffusion-weighted 219 100%
- Susceptibility-weighted 115 53%
Condition
subjects, values can overlap
- Intracerebral hemorrhage 219 100%
- Cerebral microbleeds 71 32%
License and access
Our reading of the license, not legal advice. Before you use the data, read the original license and confirm that your use is allowed. We take no responsibility for how you use a dataset. Full disclaimer
A research proposal is reviewed and approved
No published license or data use terms
The data holder has published no license and no data use terms. Any use, sharing or commercial right has to be agreed with the data holder, and nothing can be assumed to be allowed. Default copyright and data protection law still apply.
The data availability statement of Sundaresan et al. 2023 says the sub-study data "can be shared with bona fide researchers and research groups on written request to the sub-study PI" (Rob Dineen, University of Nottingham), that proposals are assessed by the PI, and that "a Data Transfer Agreement will be established before any data are shared". The agreement text is not published.
What you can do
- Commercial use Not stated
- Train ML models Not stated
- Create derived data Not stated
- Publish results Not stated
What you can share
- Share the data Not stated
- Share derived data Not stated
- Share trained models Not stated
What you must do
- Cite or credit Not stated
- Share alike Not stated
- Sign an agreement Not stated
- Ethics approval Not stated
- Manuscript review Not stated
- Release code Not stated
- Return results Not stated
- Delete after use Not stated
Limits
- No re-identification Not stated
- Location limits Not stated
Citation
Dineen RA, Pszczolkowski S, Flaherty K, Law ZK, Morgan PS, Roberts I, Werring DJ, Al-Shahi Salman R, England T, Bath PM, Sprigg N. Does tranexamic acid lead to changes in MRI measures of brain tissue health in patients with spontaneous intracerebral haemorrhage? Protocol for a MRI substudy nested within the double-blind randomised controlled TICH-2 trial. BMJ Open 8(2), e019930 (2018). doi:10.1136/bmjopen-2017-019930
All numbers
Every number on this page, as stored in stats.csv, with its source.
| Measure | Breakdown | Value | Source |
|---|---|---|---|
| Subjects | total participants with analysable brain MRI from 50 centres; 96 randomised to tranexamic acid and 123 to placebo | 219 | pszczolkowski2022 Abstract (Results) |
| Subjects | condition=intracerebral_hemorrhage acute spontaneous intracerebral haemorrhage | 219 | pszczolkowski2022 Abstract (Results) |
| Subjects | contrast=dwi analysable DWI data sets | 219 | pszczolkowski2022 Results |
| Subjects | contrast=swi SWI scans in the microbleed-labelled subset; SWI was optional in the protocol, and the number of all sub-study participants with SWI is not published | 115 | sundaresan2023 Section 3.3 |
| Subjects | condition=cerebral_microbleeds subjects with microbleed masks among the 115 SWI scans (849 microbleeds rated definite or possible, median 3 per subject); not counted for the other participants | 71 | sundaresan2023 Section 3.3 |
| Subjects | sex=male 57.5% | 126 | pszczolkowski2022 Abstract (Results) |
| Mean age | total SD 13.8 | 65.1 | pszczolkowski2022 Abstract (Results) |
| Age SD | total | 13.8 | pszczolkowski2022 Abstract (Results) |
Sources
The keys used in the table above.
- dineen2018 Dineen et al. 2018, BMJ Open, TICH-2 MRI sub-study protocol (PMC5879748) paper
- pszczolkowski2022 Pszczolkowski et al. 2022, JAMA Neurology, TICH-2 MRI sub-study results (PMC8938900) paper
- sundaresan2023 Sundaresan et al. 2023, Frontiers in Neuroinformatics, microbleed segmentations (PMC10363739) paper