|
| Trial name | Study
design | Treatment
group | Control group | Target enrollment | Outcome measure | PI | Comments |
|
| Neuroprotective drugs |
|
| Selenium to Improve Neurological Outcome after Cardiac Arrest (SCPR) | Randomized, double-blind, placebo-controlled, single-center, phase 2a efficacy study | Sodium-selenite infusion × 7 days | Placebo | 52 | Primary outcome: neuron-specific enolase
Secondary outcomes: inflammation and oxidative stress markers, NIHSS and Glasgow Pittsburgh performance score at 6 months, selenium blood levels, glutathione peroxidase plasma levels | Vanessa Stadlbauer and Karlheinz Smolle,
NCT01390506 | Selenium can reduce oxidative stress after cardiac arrest and reduce inflammation |
|
| Magnesium |
|
| Clinical Study of the LRS ThermoSuit System in Post Arrest Patients with Intravenous Infusion of Magnesium Sulfate | Randomized, double-blind, parallel assignment, safety/efficacy study of any rhythm | Thermosuit to target 34°C plus magnesium sulfate IV (30 mg/kg over 15 minutes) | ThermoSuit to target 34°C plus placebo (normal saline) | 14 | Primary outcome: cooling rate
Secondary outcomes: time to target temperature, percentage of time in target temperature range, shivering, length of stay, neurologic status at discharge and 6 months, adverse events, survival at 24 hours, discharge and 30 days | Michael Holzer and Andreas Janata, NCT00593164 | Tests new device to achieve therapeutic hypothermia and the impact of magnesium on cooling performance and hemodynamics |
|
| Hypothermia |
|
| Target Temperature Management after Cardiac Arrest (TTM) | Randomized, double-blind, parallel assignment, multicenter, safety/efficacy trial for out-of-hospital cardiac arrest | Target temperature 36°C × 24 h | Target temperature 33°C × 24 h | 850 | Primary outcome: All cause mortality
Secondary outcomes: 6-month composite all cause mortality and poor neurological outcome by cerebral performance scale, bleeding, 6-month neurological status and quality of life, mRS, Cerebral performance scale, mini-mental test, IQCODE, SF-36, adverse events | Niklas Nielsen and Hans, Friberg NCT01020916 | Attempts to identify optimal hypothermia target temperature |
| Hypothermia After in-Hospital Cardiac Arrest (HACAinhospital) | Randomized, single-blind, parallel assignment, single-center, safety/efficacy study for in-hospital arrests of any rhythm | Mild therapeutic hypothermia 32–34°C × 24 hours. | Standard care, no hypothermia | 440 | Primary outcome: all cause mortality at 6 months
Secondary outcomes: 6 month Glasgow-Pittsburgh cerebral performance scale, in-hospital all-cause mortality | Sebastian Wolfrum and Volkhard Kurowski,
NCT00457431 | Tests whether hypothermia treatment will improve outcome after in-hospital arrest of any rhythm |
| Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest (HITUPPAC-BIO) | Randomized, open label, parallel assignment, efficacy trial | Hypothermia induction prehospital | Hypothermia induction at hospital arrival | 250 | Primary outcomes: brain injury biomarkers at 72 h
Secondary outcomes: ROSC, survival 72 h, GCS at 48 hours, cerebral performance scale at 28 days | Guillaume Debaty Jean Francois Timsit, NCT00886184 | Assess utility of early hypothermia prehospital |
| Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest | Randomized, open label, single group assignment, efficacy study of any rhythm out of hospital arrest | Rapid infusion of 2 L of 4°C normal saline prior to ED arrival | Standard therapy | 1364 | Primary outcome: awake and command following at hospital discharge
Secondary outcomes: days to awakening, days to death, 3 month neurological outcome | Francis Kim,
NCT00391469 | Tests whether rapid induction of hypothermia with cold saline infusion is efficacious |
| Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients | Randomized, open label, parallel assignment, efficacy trial | External device (Arctic Sun) induced hypothermia | Internal device (Alsius) induced hypothermia | 51 | Primary outcome: Survival to hospital discharge
Secondary outcome: 1 year neurological status | Marcus Ong, NCT00827957 | Identifying the most efficient method of cooling may improve outcome after cardiac arrest |
|
| Hypothermia + ECMO |
|
| Refractory Out-of-Hospital Cardiac Arrest Treated with Mechanical CPR, Hypothermia, ECMO and Early Reperfusion (CHEER) | Nonrandomized, single group, open label, safety/efficacy trail for patients who fail standard resuscitation | Automated CPR, ECMO, coronary angiography, therapeutic hypothermia | NA | 24 | Primary outcome: survival to hospital discharge
Secondary outcomes: cerebral performance Scale, time to ECMO insertion, neurologic biomarkers, cardiac recovery | Stephen Bernard and Dion Stub, NCT01186614 | Aggressive resuscitation may improve outcome in patients who fail standard resuscitation |
| Hyperinvasive approach to out-of-hospital cardiac arrest using mechanical chest compression device, prehospital intraarrest cooling, extracorporeal Life support and early Invasive assessment compared to standard of care: Prague OHCA Study | Randomized, open-label, parallel group, safety/efficacy study | Prehospital mechanical compression device, intraarrest cooling and in hospital ECLS (compression device, Rhinochill, PLS ECMO) | Standard care | 170 | Primary outcome: composite endpoint of survival with good neurological outcome (cerebral performance scale)
Secondary outcome: 30 day cerebral performance scale, 30 day cardiac recovery | Jan Belohlavek and Ondrej Smid,
NCT01511666 | Aggressive, early intervention may improve cerebral outcomes |
| Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest from Trauma (EPR-CAT) | Nonrandomized, open label, parallel assignment, safety/efficacy study | Profound hypothermia < 10°C with cold saline infusion into aorta followed by resuscitation/rewarming with cardiopulmonary bypass | Standard treatment | 20 | Primary outcome: survival to hospital discharge without major disability by GOSE
Secondary outcomes: achieving target temperature in 1 hour, 28 day survival, 6 month neurological function, multiple organ system dysfunction | Samuel Tisherman,
NCT01042015 | Resuscitation technique for trauma patients that have arrested from exsanguination |
|
| HypotherMia + xenon |
|
| Effect of xenon and therapeutic hypothemia on brain and on neuroloigcal outcome following brain ischemia in cardiac arrest patients (Xe-hypotheca) | Randomzied, open label, parallel assignment, phase 2 safety/efficacy trial for ventricular fibrillation and nonperfusing ventricular tachycardia | Hypothermia 33°C × 24 h and Xenon inhalation × 24 hours target end tidal 40% | Hypothermia 33°C × 24 h | 110 | Primary outcome: PET and MRI ischemia at 24 hours and 10 days
Secondary outcomes: neurological outcome at 6 months, TTE | Timo Laitio,
NCT00879892 | Xenon may be synergistically neuroprotective in combination with hypothermia post arrest by limiting cerebral hypoxia, neuronal loss, and mitochondrial dysfunction |
|
| Chest compresions |
|
| Continuous chest compressions | Randomized, open label, multicenter, crossover assignment study of out-of-hospital cardiac arrest of any rhythm | Continuous chest compressions | Interrupted chest compressions with ventilation 30 : 2 | 23600 | Primary outcome: survival to hospital discharge
Secondary outcomes: mRS at discharge, adverse events | Myron Weisfeldt,
NCT01372748 | Continuous CPR without interruption for ventilation may be superior to interrupted compression with ventilation ratio of 30 : 2 |
| LUCAS chest compressor versus manual chest compression in out-of-hospital sudden cardiac arrest: LUCAT trial | Randomized, open label, parallel assignment, efficacy study | Mechanical continuous chest compressions performed by LUCAS device | Manual chest compressions | 400 | Primary outcome: survival to hospital admission, survival to discharge with good neurological state by cerebral performance Scale
Secondary outcomes: ROSC, end tidal CO2, SOFA scale, length of stay, metabolic and inflammatory markers, LV function | Francesc Carmona Jimenez, Rosa-Maria Lidon,
NCT01521208 | Mechanical chest compression may be superior to manual chest compression |
|
| Cerebral oxygenation |
|
| Cerebral Oxygenation in Cardiac Arrest and Hypothermia | Open label, safety and efficacy study | Near-infrared monitoring | Standard therapy, no monitoring | 70 | Primary outcome: survival to discharge
Secondary outcomes: cerebral performance scale at discharge and 12 months | Christian Storm, NCT01531426 | Near-infrared spectroscopy (NIRS) could be a new-noninvasive marker for outcome after cardiac arrest. Low NIRS may correlate with poor outcome |
|
