Deans' stroke musings: Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): An international randomised, placebo-controlled, phase 3 superiority trial

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Monday, May 21, 2018

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

So it didn't really help. Nice to see a negative research finding being published.
https://www.mdlinx.com/journal-summaries/tranexamic-acid-hematoma-stroke-intracerebral-hemorrhage/2018/05/21/7521061/?

The Lancet — Sprigg N, et al. | May 21, 2018

An international, randomized placebo-controlled trial was performed to evaluate if tranexamic acid lessens hematoma expansion and improves outcomes in adults with stroke due to intracerebral hemorrhage. Despite a decrease in early deaths and serious adverse events, functional status 90 days following intracerebral hemorrhage did not differ significantly among patients who received tranexamic acid vs those who received placebo.

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Methods

This trial was conducted on adults with intracerebral hemorrhage from acute stroke units at 124 hospital sites in 12 countries.
Members were randomized (1:1) to receive 1g intravenous tranexamic acid bolus followed by an 8-hour infusion of 1g tranexamic acid or a matching placebo, within 8 hours of symptom onset.
Randomization happened centrally in real time via a secure website, with stratification by country and minimization on key prognostic factors.
Treatment allocation was hidden from patients, outcome assessors, and all other health-care workers involved in the trial.
Using ordinal logistic regression with adjustment for stratification and minimization criteria, the primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale.
All examinations were done on an intention-to-treat basis.

Results

Between March 1, 2013, and Sept 30, 2017, 2,325 participants were recruited.
One 1,161 patients received tranexamic acid and 1,164 received placebo; the treatment groups were well balanced at baseline.
For 2,307 (99%) participants, the primary outcome was assessed.
They observed that the primary outcome did not differ significantly between the groups (adjusted odds ratio [aOR] 0.88, 95% CI 0.76–1.03, p=0.11).
Findings revealed that, although there were fewer deaths by day 7 in the tranexamic acid group(Except for this positive) (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).
It was observed in the findings that fewer patients had serious adverse events after tranexamic acid vs after placebo by days 2 (379 [33%] patients vs 417 [36%] patients)(Except for this positive), 7 (456 [39%] vs 497 [43%]), and 90 (521 [45%] vs 556 [48%]).