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45 active trials for Out of Hospital Cardiac Arrest

Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors

Reliable data on stent thrombosis (ST) in comatose out of hospital cardiac arrest (OHCA) survivors is lacking. In comatose OHCA survivors suspicion of ST can be made with precise clinical monitoring of the patient with definite confirmation being possible only by coronary angiography or autopsy of deceased patients. However in addition to definite ST which can be confirmed using current protocols, additional ST which are clinically silent are plausible. These could be identified only by systematic coronary angiography of all OHCA survivors or by autopsy of deceased patients. Collectively with definite ST confirmed by coronary angiography upon clinical suspicion the incidence of all forms of ST in survivors of OHCA treated with PCI and hypothermia could be obtained. Consecutive comatose survivors of OHCA treated with percutaneous coronary intervention (PCI) and hypothermia will be included. All study participants will receive treatment per our established clinical protocol and will be followed for 10 days. In all patients in whom clinical suspicion of ST will be made immediate coronary angiography and if necessary PCI will be carried out. In all patients that will die in the observed period of 10 days autopsy will be performed. Survivors however will have an additional control coronary angiography on 10th day after admission, to assess presence of clinically silent ST. We expect that the incidence of true definitive ST in comatose OHCA survivors treated with urgent PCI with stenting and hypothermia is greater than one, which is confirmed on the basis of clinical suspicion by angiography or later with autopsy.

Start: August 2016

EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest

Sudden cardiac death (SCD) remains a major public health issue with a low survival rate. The most common cause of SCD is acute coronary artery occlusion. Several registry based studies suggest that coronary angiography (CA) performed at admission followed if necessary by coronary angioplasty improves in-hospital and long term survival. Recent guidelines recommend performing an immediate CA in all survivors of SCD with no obvious non cardiac cause of arrest. However there is a lack of randomized data on this topic. Several retrospective studies have shown that if the post-resuscitation electrocardiogram (ECG) shows ST segment elevation, the probability of finding an acute coronary artery lesion during the CA is high (70-80%). In contrast, if no ST segment elevation is present the probability is low (15-20%). Performing an immediate CA in all survivors of SCD can be challenging. It requires admitting these patients to centers with an intensive care unit and facilities allowing 24/24 7/7 CA. It may increase the delay of performing other therapeutic modalities such as CT brain or thorax scan to determine the cause of SCD. Performing the CA 48 to 96 hours after admission would facilitate the management of these difficult patients. However if the cause of the arrest is a coronary artery occlusion and there is a delay in reperfusion, the rate of post-arrest shock and the mortality may increase. Therefore a randomized study comparing immediate versus delayed (between 48 to 96 hours) CA in survivors of SCD with no obvious non-cardiac cause of arrest is warranted.

Start: January 2017

Compression Only CPR Versus Standard CPR in Out-Of-Hospital Cardiac Arrest - A Randomized Survival Study

Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of mortality in the industrialized world. Bystander CPR before arrival of the Emergency Medical Service (EMS) is associated with an increased chance of survival. During the last decade, the best form of bystander CPR has been debated. Chest Compression Only CPR (CO-CPR) has been advocated as a preferable method in situations where the bystander has no previous knowledge in CPR, both because its believed to be equally efficient but also a simplified form of CPR that could lead to a higher incidence of bystander-CPR. In an initiative to increase CPR rates the American Heart Association has launched public campaigns such as the "hands-only CPR" promoting CO-CPR as an option to S-CPR for adult non-asphyxic cardiac arrest. In the 2015 updates of the European resuscitation council guidelines it states that the confidence in the equivalence between the two methods is not sufficient to change current practice. Whether CO-CPR leads to a survival rate no worse than, equally effective, or even superior to standard CPR in situations where the bystander has previous CPR training however remains unclear. This clinical question remains unanswered while millions of people are trained in CPR worldwide each year. The overall purpose with this research project is to investigate whether instructions to perform a simplified form of CPR consisting of compressions only (CO-CPR) to bystanders with prior CPR-training is non-inferior, or better than, standard CPR (S- CPR) in witnessed Out-of-Hospital Cardiac Arrest (OHCA).

Start: January 2017

Factors Associated With CPC 1-2 in 110 Patients Admitted in French ICU for a Myocardial Infarction Complicated by an OHCA.

This study evaluate the association of some in-ICU factors with the neurological prognosis of patients admitted for an out-of-hospital cardiac arrest due to a myocardial infarction.

Start: October 2020

Blood Pressure and OXygenation Targets After OHCA

This study compares two blood pressure targets and two oxygenation targets in the post-resuscitation care of comatose out-of-hospital cardiac arrets patients. Using a novel method the blood pressure-intervention is double-blinded. The oxygenation-intervention is open-label. As a subordinate study, the patients will be randomized 1:1 to active fever-control with an automated feedback temperature control-device for 36 or 72 hours following return of spontaneous circulation.

Start: March 2017

Dynamics of the Capillary Lactate Levels in OHCA

Serial capillary lactate measurements during cardiopulmonary resuscitation (CPR) in patients with out-of-hospital cardiac arrest (OHCA).

Start: April 2019

Compression Only-CPR Versus Standard-CPR

Start: January 2017

Reduction of Oxygen After Cardiac Arrest

The Reduction of oxygen after cardiac arrest (EXACT) is a multi-centre, randomised, controlled trial (RCT) to determine whether reducing oxygen administration to target an oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful resuscitation from OHCA improves outcome at hospital discharge.

Start: December 2017

Cardiac Arrest in Residential Areas With Mobile First-responder Activation

The study aims to increase proportions of bystander defibrillation during out-of-hospital cardiac arrest (hereof referred to as cardiac arrest) in residential areas with a high density of cardiac arrests. The intervention consists of Automated External Defibrillators (AEDs) and residents' involvement in resuscitation through training and enrollment as citizen responders.

Start: June 2020

Geographical Association Between Basic Life Support Courses, Bystander Cardiopulmonary Resuscitation and Survival

Background Since 2001 when the Danish Cardiac Arrest Registry was first established several large-scale interventions aimed at the entire Danish population from all ages have been initiated. BLS courses have been made mandatory in all primary schools since January 2005, and when taking driver's license since October 2006. This has resulted in a steep increase in the number of Danish citizens attending a BLS course to approximately 3-4.5% of the entire population annually. Aim The aim of this study is to investigate the effect of the numerous population-based interventions to increase bystander basic life support (BLS) prior to arrival of Emergency Medical Services (EMS) to persons suffering from out-of-hospital cardiac arrest (OHCA). Further this study aim at identifying geographical areas with low frequency of Basic Life Support (BLS) education and low level of bystander initiated BLS to enable direction of further educational efforts in the future to increase survival. Methods By coupling the geographical coordinates of the BLS course certificates with the GPS coordinates of cardiac arrests, the effects of BLS courses on bystander CPR rates and survival can be investigated. In collaboration with researchers from Aalborg University Hospital, the entire Danish geography have been divided into digital squares of 100x100m and combined with sociodemographic data. This data will be coupled with national administrative parish of Denmark comprising some 2201 geographical units of approximately equal size. This geographic model has been combined with data from the Danish Cardiac Arrest Registry, the National Danish Patient registry and the Central Person Registry. The current study has access to the geodata of the GPS coordinates of Danish citizens who have attained a BLS course certificate between 2016 and 2019. By combining the two datasets in national administrative parish's of Denmark, the investigators are able to calculate the correlation between BLS course certificates, the rate of bystander CPR and survival of OHCA. Further, the investigators are able to pinpoint geographic areas where improvements of the BLS education level and bystander initiated BLS rates can be made. To involve laypersons in the current study, focus group interviews consisting of BLS course participants will be performed to explore the views of the attending laypersons on the project and revise accordingly. Expected outcome To identify geographical association between bystander CPR prior to EMS arrival and BLS training. A verified account of number of BLS certificates issued annually and geographical visual map of first aid certificates. Finally, it is a goal to be able to identify areas with which to start with better education. That is, areas where there is low frequency of courses and low frequency of bystanders initiated BLS.

Start: January 2020

A Randomised Trial of Expedited Transfer to a Cardiac Arrest Centre for Non-ST Elevation Out-of-hospital Cardiac Arrest

The aim of ARREST is to determine the best post-resuscitation care pathway for out of hospital cardiac arrest patients without ST-segment elevation. The investigators propose that changes to emergency management comprising expedited delivery to a specialist heart attack centre with organised post-cardiac arrest care including immediate access to reperfusion therapy will reduce mortality in patients without STE compared to the current standard of care, which comprises protracted pre-hospital management of the patient without definitive care plan and delivery to geographically closest hospital.

Start: February 2018

ORI to Reduce Hyperoxia After Out Hospital Cardiac Arrest

The investigator's research proposal is a randomized controlled study evaluating two different monitoring strategies to titrate FiO2 in order to rapidly and safely achieve optimal SatO2 targets during early ROSC of non-traumatic OHCA in adults. Primary hypothesis: Monitoring transport to hospital of sustained ROSC of OHCA patients using multiple wavelength detectors that allow ORI continuous measurement will reduce hyperoxia and hypoxia burden associated with transport. Secondary hypothesis: Multiple wavelength detectors allowing ORI continuous measurement will reduce hyperoxia at ER admission as measured via blood gas analysis. Tertiary study hypothesis: Multiple wavelength detectors allowing ORI continuous measurement will reduce reperfusion neuronal injury measured through NSE levels at 48h post ROSC

Start: November 2018

Feasibility and Safety of Delivering a Ketone Drink to Comatose Survivors of Out-of-hospital Cardiac Arrest

Every year, efforts are made to resuscitate about 30,000 people when their hearts stop outside of the hospital environment ('out-of-hospital cardiac arrest'). Early damage to the brain due to 'oxygen starvation' (seemingly paradoxically) gets worse when blood flow is restored. Of the 6,350 survivors admitted to intensive care units, 46% die from brain damage, and half of those who survive suffer long-term brain damage. Apart from avoiding a high temperature, nothing has been found which can protect the brain or improve outcome. 'Ketones' are chemicals naturally produced in the body from fat during starvation. They act as an energy source, but also as regulators of metabolism, and appear to protect cells from damage when oxygen supplies are scarce, or when blood flow is restored. The investigators want to see whether a ketone drink will protect the brain after out-of-hospital cardiac arrest. The investigators will study 10 cardiac arrest patients, and participants will be given the ketone drink via a feeding tube (which is routinely passed into the stomach in such cases). The investigators shall check that the drink is absorbed, and measure the ketone levels in the blood. The investigators will also measure important aspects of blood chemistry (including pH and blood sugar) and collect data on brain (electrical recordings called 'EEG' and 'SSEP') and heart function (ultrasound scans or 'echocardiographs') - both of which it is hoped might improve - in order to demonstrate that this is possible if it is to be included in a subsequent large trial. The study will be scrutinised by world experts in the field, who have also helped design the study. If this pilot study is a success, the investigators will apply to a major grant body to fund an appropriately-powered randomised controlled trial to determine whether ketones improve neurological outcome and survival in these patients. Results will also allow similar studies to be planned in heart attack, stroke and traumatic brain injury.

Start: March 2018

Silesian Registry of Out-of-Hospital Cardiac Arrest

Silesian Registry of Out-of-Hospital Cardiac Arrest (SIL-OHCA) which is an initiative of the Voivodeship Rescue Service in Katowice in cooperation with the Silesian Center for Heart Diseases in Zabrze is a prospective, population-based registry of out-of-hospital cardiac arrest (OHCA). The main aim of the SIL-OHCA is to asses the frequency of OHCA in the population of Upper Silesia and analyze prognostic factors for long-term survival in patients with OHCA.

Start: January 2018

Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest

The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the intensive care unit. This therapy is cost free and, if shown to be effective, will improve thousands of lives, transform clinical practice, and yield major savings.

Start: February 2018

Intraosseous Versus Intravenous Vascular Access During Resuscitation Following Out-of-Hospital Cardiac Arrest

Background: Intraosseous (IO) access is a new, fast, safe and efficient route of rescue of critically ill patients. Studies found drug pharmacokinetics and pharmacodynamics of IO are similar to IV route. Compared with IV and CVC, IO is time-consuming, easy to grasp, and has high operation success rate. Guidelines recommend IO when the establishment of vascular access is difficult or impossible. Recent animal studies suggest that IO access have better ventricular fibrillation termination rates, ROSC rates and survival compared with IV route. However, recent retrospective clinical studies found that IO versus IV treatment was associated with a lower likelihood of ROSC and hospitalization. How routes of vascular access influence clinical outcomes after OHCA merits multicenter randomized controlled trial. We suppose IO versus IV treatment is associated with a higher likelihood of ROSC and hospital and discharge survival. Materials and methods: Study design This study is a prospective, open, two-arm, multicenter randomized controlled trial. The study will be conducted by 22 medical centers or affiliated hospitals in China. We will enroll nearly 2356 OHCA patients by the eligibility and exclusion criteria during January 2020 to December 2022. All of the patients will be randomized to one of 2 routes of vascular access: tibial intraosseous or peripheral intravenous. Other treatment measures of two groups refer to 2015 AHA Advanced Cardiovascular Life Support guidelines. Statistical analysis Intention-to-treat analysis (ITT) and per-protocol set (PPS) sensitivity analysis will be conducted in our study. Categorical variables are presented as counts and percentages, and differences are analyzed using the ?2 test. Continuous variables are presented as means with standard deviations or median (interquartile range [IQR]), and analysis is done by the Student t test or the Mann-Whitney U test according to normal or non-normal distributions. Sample Size Calculation Set the following assumptions: alpha 0.025, beta 80%, clinically significant difference of 5% and 25% ROSC rate for both arms. Assuming the sample has an equal number of subjects in each arm, the study need to include at least 1178 subjects per arm to reach statistical significance.

Start: June 2020

Foreign Body Airway Obstruction, Incidence, Survival EMS-treatment and First Aid Treatment by Laypersons

Background: Foreign body airway obstruction (FBAO) is often described as an uncommon cause of Out of Hospital Cardiac Arrest (OHCA) accounting for approximately 1.4% of all OHCA. Reported incidents rates of FBAO causing cardiac arrest are unclear, and first aid by layperson are not well described. The aim of the epidemiological part of the study is: to investigate information on actions taken by EMS-personnel and laypersons to investigate outcomes of hypoxic Cardiac Arrest due to foreign body airway obstruction in Denmark to increase overall survival. propose new guidelines and strategies to increase survival from OHCA caused by FBAO. The aim of advanced text-string search algorithm part of the study is - To investigate if an advanced text-string search algorithm can identify FBAO in medical records with high sensitivity Methods: National data will be collected from the verified 2016-2019 Danish OHCA register, and cases with FBAO prior to OHCA will selected via a direct marking by external validation and advanced text search. Patients reported as indisputably deceased (late signs of death) was excluded. Incidence rates per 100.000 citizens, survival rates to hospital and first aid actions by layperson are presented. A pilot study have been conducted in regional data from 2016-2019 and the study group have concluded that, a national study is feasible with the current amount of data and the used methodology. Expected outcome: This study will enable targeted campaigns aimed at increasing survival from OHCA caused by FBAO. Potential campaigns might target the food items provided to potential vulnerable groups and guide focus for first aid recommendations. Further, with a deeper understanding of which airway management procedures most often are successful, it will be possible to improve EMS treatments of vulnerable groups. Finally, a novel method of extracting information from the electronic medical records will be developed creating the foundation for future works on other prehospital conditions

Start: February 2019

Etiology, Incidence and Survival of Pediatric Out-of-hospital Cardiac Arrests: a Four-year Danish Analysis

Background: OHCA is a rare condition for children and young adults. Overall incidence rates are reported as 3.3-5.97 per 100.000 inhabitants. Previous studies from different data sources have identified a diverse and slightly incompatible etiologies. The purpose of this investigation was to analyze presumed etiologies of pediatric OHCA and report incident and survival rates. Further the investigators wish to present central characteristics of pediatric OHCA in Denmark. Methods: Data will be collected from the verified 2016-2019 Danish OHCA register. Inclusion criteria were age ? 16 years at the time of the event. All included EMS reports will read by two authors [MGH and TWJ] and the presumed reversible cause assigned to each case. Incidence rates per 100.000 citizens, survival rates to hospital, initial rhythm, use of AED by laypersons, EMS treatment and presumed etiology are reported. To test feasibility a study was conducted in 2018, on the 56 verified cases of children with OHCA was reported in the capital region of Denmark in 2016-2018 (among 1.8 million inhabitants). Incident rates were 0.83-1.34 per 100.000 inhabitants per year. Preliminary data show survival to hospital was 46% which was markedly higher than the adult population (28%, p = 0.002). The most common cause of OHCA was hypoxia (50%) followed by trauma/hypovolemia (14%) and others (7%). Approximately 23% did not present with an apparent etiology. Hereditary disorders as the primary cause was noted in 7% of the cases. The conclusion from the feasibility study is that the study is possible and that a reasonable proportion of pediatric OHCA can be analyzed from EMS medical reports. Expected outcome: Variables included in the study: age, gender, initial rhythm, etiology of cardiac arrest, event location, observation of occurrence, cardio-pulmonary-resuscitation (CPR), defibrillation and use automatic external defibrillators (AEDs), EMS-response time, hospitalization, return-of-spontaneous-circulation (ROSC), state at hospital admission, 30-day survival, airway management and use of epinephrine. See the dedicated study protocol for an extended description of the variables and associated analyses.

Start: February 2019

CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- a Descriptive Study

The aim with this descriptive multicenter study is to examine the quality of the ventilation given by Emergency Medical Service (EMS) personnel during cardiopulmonary resuscitation (CPR). Primary endpoint is the ventilation quality measured as ventilation frequency, tidal volume and minute ventilation. This will primarily be studied during CPR with a 30 compression/2 ventilation ratio performed by the EMS personnel where the airway is managed with a supraglottic device but also in CPR with continuous ventilation (8-10 breaths/minute) after the airway management have been replaced with an endotracheal within the emergency room. The inclusion of patients will be performed at two sites (Uppsala; Sweden and Utrecht; Holland), all out-of-hospital cardia arrest (OHCA) patients will receive care according to current CPR guidelines using mechanical chest compressions.

Start: March 2019

Out of Hospital Cardiac Arrest: Trial Assessing the Survival Impact of Phone Advice

Medical call center have no phone advice protocol within out of hospital cardiac arrest in France. The purpose of the present study is to compare a group of patients with protocol phone advice delivered by the dispatchers ("CONTARM" group) versus usual phone advice ( "CONTHAB" group). Comparison will be performed on survival to seven days. The hypothesis is that CONTARM group has an higher survival at seven days. A second goal is to measure the survival to 15 and 30 days. The trial is randomized, controlled and will include 2600 patients. The patients will be enrolled in 19 hospitals in France.

Start: September 2016