Last I heard, this trial (https://www.thapca.org/) was completed, and results were about to be published, however have not seen anything yet. Anyone have any updates or knowledge?
Thanks in advance,
Erik
No, this is just a case report of two example patients. The full trial enrolled almost 1000 patients...
Unfortunately no intermediate results are available. Thus we may just hypothesize that therapeutic hypothermia after pediatric cardiac arrest does not worsen the outcome. According to the design of the study, Moler et al objective was to enrolled 900 pediatric cardiac arrests between September 2009 and September 2015.
To date, only “Nursing perceptions and association with approach rates in the THAPCA trials” (CCM dec 2014 A 1433) or discussion about the assessment timing are published, without any information about the number of cases enrolled.
Thus, in absence of any recommendations for clinical practice (Cohrane syst review 2013), a targeted temperature of 36 should be discussed, as proposed for the adults. Moreover, 36 targeted temperature induces less cardiovascular instability, lower lactate levels, and lower vasopressor support (Bro-Jeppesen et al Post hoc analysis, CCM 2015, published ahead of print)…..
It has not proved effective, there appears to be some benefit to a near drowned child whose exposure is in cold water, but no one can prove that cooling after arrest is beneficial.
Quite the contrary; the THAPCA study had a profound effect size favoring the colder arm, and showed statistical significance in outcome (albeit, this was buried in the appendix, so those that don't read the whole article will miss it).
From the point estimates, we're looking at a Number Needed to Treat (NNT) of 12.5 (20% vs. 12% to primary outcome of survival at 12 months after cardiac arrest with a VABS-II score of 70 or higher). This is amazingly large. And an overall 1-year survival of 38% in the hypothermia group vs. 29% in the normothermia group gives us an NNT of 11.
This study was underpowered to find the statistical significance, but that shouldn't affect the obvious effect size signal. The goal was 276 patients, the analyzed number was short of that, and the sensitivity analysis (reported only in the Supplementary Appendix), despite being downplayed somewhat, suggests that in fact the results were quite close to crossing into significance had the trial ran a bit longer.
Survival over time was significantly longer with therapeutic hypothermia than with therapeutic normothermia (mean survival, 149±14 days vs. 119±14 days; P = 0.04 for the comparison of survival between the two treatment groups by means of the log-rank test) (Fig. S1 in the Supplementary Appendix). Looking at Figure S1 (way down on page 22 of the Supplementary Appendix), I think it's pretty clear which arm you'd put your loved one in if faced with that decision.
The authors rightly emphasize though that this was not a study against a non-treated arm, but rather was a comparison between two very rigorously treated arms (for out to 120 hours).
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