BrainCool AB (publ) - The PRINCESS study published in JAMA
(The Journal of the American Medical Association, May 7th, Volume 321, Number 17)
The aim of the PRINCESS trial (Pre-hospital Resuscitation Intra arrest Cooling) was to evaluate whether the addition of intra-arrest therapeutic hypothermia, initiated in the field with trans nasal evaporative cooling (RhinoChill™), compared to standard ACLS (Advanced cardiovascular life support ) would provide benefits in survival with good neurologic outcome in patients with out-of-hospital cardiac arrest.
The study was a randomized clinical trial conducted in 11 emergency medical systems (EMS) in 7 European countries, including 677 out-of-hospital cardiac arrest patients. The PRINCESS trial shows that RhinoChill is a method that can be used for safe initiation of cooling already at the scene of the arrest. This new information is very important as previous prehospital cooling methods have been associated with significant hemodynamic adverse effects. Thus, in this study an ‘intensive care treatment’ as cooling has safely been applied by the regular EMS personnel at the scene of the cardiac arrest, which significantly has shortened the time to reach the very important target temperature.
"This cooling method we used in this study is unique in many ways- because this treatment of patients in cardiac arrest can start directly at the site of the arrest or at the latest in the ambulance. This is important new information for all clinicians. We now have a method to be used already in the ambulance without any serious side effects," says professor in cardiology Leif Svensson at Karolinska Institutet who has been one of the leaders of the study.
"Previously published studies have shown that cooling in the ambulance has been done by injecting cold liquid intravenously into the blood, which entailed great risks for the patient since this extra fluid can cause strain on the heart and lead to new cardiac arrest," says Per Nordberg, the principal researcher for the study and working at the Center for cardiac arrest at Karolinska Institutet.
The difference in good neurological outcome, using the most common (CPC 1 and 2), at 90 days was 16,6 % in the cooling group compared with 13,5 % in the standard of care group, a difference that did not lead to statistical significance.
“In the most interesting subgroup of patients, those with ventricular fibrillation as initial rhythm, the difference was as big as almost 10% absolute difference (34.8% versus 25.9%) in favor of intra-arrest cooling. This is sensational” ads professor Leif Svensson, Karolinska Institutet Stockholm Sweden, investigator of many landmarks prehospital trials.
Although a post hoc finding, there was also an interesting significant improvement in complete recovery (CPC 1) among patients with ventricular fibrillation.
Survival is of course important. However, survival with improved or complete neurological recovery is the ultimate goal to reach for all patients, not only in cardiac arrest patients. I see similarities in the treatment of stroke patients, says professor Svensson.
Additionally, the technology has also be used for the first time combining thrombectomy and hypothermia treatment in acute stroke patients this with the combination of the two BrainCool technologies, the RhinoChill™ and the BrainCool™ System, resulting in a one-product offer – the BrainCell concept. All with the ambition to open the artery and improve neurological outcome. Cardiac arrest and stroke treatment are very similar. In both patient categories treatment has to be start as soon as possible.
BrainCool’s CEO Martin Waleij comments;
- The publication in the high ranked scientific journal JAMA will result in a huge interest in the treatment method and the product RhinoChill. Early, safe and efficient temperature reduction using RhinoChill provides targeted neuro protection of the brain.
With the first publication out, we will plan for a number of presentations and satellite meetings of the PRINCESS trial and the BrainCell concept with researchers from Sweden, Germany, and Belgium. Although a number of unofficial presentations already have been held (pre-presentations) they have been limited in terms of providing all information until today’s publication in JAMA.
In BrainCool´s pursuit of improvements and apply early cooling methods in hypothermia treatments of both cardiac arrest and stroke patients, we humbly note that major competitors in the space also have had pre-presentation of the PRINCESS trial.
Following the first publication derived from the clinical study of PRINCESS focusing on the primary outcome, we also expect that several other publications - such as an meta-analysis of the PRINCE AND PRINCESS and a time analyses of how patients results is effected by applying cooling in different time intervals – will result in further clinical evidence and even more interest in the concept.
For more information
Martin Waleij - CEO
+46 - 733 -93 70 76
E-mail: martin.waleij@braincool.se
About BrainCool AB (publ)
BrainCool AB (publ) is an innovative medical device company that develops, markets, and sells leading medical cooling systems for indications and areas with significant medical benefits within the healthcare sector. The company focuses on two business segments, Brain Cooling and Pain Management. BrainCool AB (publ) is based in Lund, Sweden, and its share is listed on Spotlight Stock Market.
The BrainCell concept is the unique combination and integration of the BrainCool™ System and the RhinoChill™ System, the only portable medical cooling system to deliver targeted cooling to the brain, significantly earlier than conventional cooling methods. This will enable health-care personnel to easily and effectively initiate cooling of the brain. The RhinoChill™ System can be used immediately after the SCA or stroke, in the ambulance or the hospital emergency department (ED). In the ICU, the BrainCool™ System will be implemented for long-term cooling during multiple days, completing the chain of treatment.