Cardiac Arrest Clinical Trial
— THAPCA-IHOfficial title:
Therapeutic Hypothermia After Pediatric Cardiac Arrest (In Hospital)
Verified date | May 2018 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully treat adults who have experienced cardiac arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing survival rates and reducing the risk of brain injury in infants and children who experience a cardiac arrest while in the hospital.
Status | Completed |
Enrollment | 329 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Patient suffered cardiac arrest requiring chest compressions for at least 2 minutes (120 seconds) with ROSC/ROC; AND - Age greater than 48 hours (with a corrected gestational age of at least 38 weeks) and less than 18 years; AND - Patient requires continuous mechanical ventilation; AND - The cardiac arrest was unplanned (i.e., not part of cardiac surgical procedure) Exclusion Criteria: - The parent or legal guardian does not speak English or Spanish (the only two languages in which VABS II is standardized) - Randomization is impossible within six hours of ROSC; OR - Patient is on extracorporeal membrane oxygenation (ECMO) when arrest occurs; OR - Continuous infusion of epinephrine or norepinephrine at very high doses (=2 ug/kg/minute) received immediately prior to randomization; OR Glasgow Coma Scale motor response of five (localizing pain or for infants less than two years, withdraws to touch) or six (obeys commands, or for infants, normal spontaneous movement) prior to randomization; OR - History of a prior cardiac arrest with chest compressions for at least two minutes during the current hospitalization but outside the 6 hour window for randomization; OR - Pre-existing terminal illness with life expectancy < 12 months; OR - Lack of commitment to aggressive intensive care therapies including do not resuscitate orders and other limitations to care; OR - Cardiac arrest was associated with severe brain, thoracic, or abdominal trauma; OR - Active and refractory severe bleeding prior to randomization; OR - Near drowning in ice water with patient core temperature =32 °C on presentation; OR - Patient is pregnant; OR - Patient participation in a concurrent interventional trial whose protocol, in the judgment of the THAPCA investigators, prevents effective application of one or both THAPCA therapeutic treatment arms, or otherwise significantly interferes with carrying out the THAPCA protocol; OR - Patient is newborn with acute birth asphyxia; OR _ Patient cared for in a neonatal intensive care unit (NICU) after arrest (ie, would not be admitted to PICU); OR - Patient has sickle cell anemia; OR - Patient known to have pre-existing cryoglobulinemia; OR - Central nervous system tumor with ongoing chemotherapy or radiation therapy; OR - Chronic hypothermia secondary to hypovolemic, pituitary, or related condition for which body temperature is consistently below 37 °C ; OR progressive degenerative encephalopathy; OR - Any condition in which direct skin surface cooling would be contraindicated, such as large burns, decubitus ulcers, cellulitis, or other conditions with disrupted skin integrity (NOTE: patients with open chest CPR should be included but placement of cooling mattresses will be modified as needed); OR - Previous enrollment in the THAPCA Trials. |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
United Kingdom | Birmingham Children's Hospital | Birmingham | |
United Kingdom | Bristol Royal Hospital for Children | Bristol | |
United Kingdom | University of Hampton | Hampton | |
United Kingdom | Alder Hey Children's Hospital | Liverpool | |
United Kingdom | Evalina Children's at Guys's and St. Thomas' Hospital | London | |
United Kingdom | Great Ormand Street Hospital | London | |
United Kingdom | Royal Manchester Children's Hospital | Manchester | |
United States | University of Michigan, Mott Children's Hospital | Ann Arbor | Michigan |
United States | Children's Hospital of Atlanta/Emory University | Atlanta | Georgia |
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | The Children's Hospital of Alabama | Birmingham | Alabama |
United States | Nationwide Children's Hospital in Columbus | Columbus | Ohio |
United States | Children's Medical Center Dallas | Dallas | Texas |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | Duke Children's Hospital | Durham | North Carolina |
United States | Penn State Children's Hospital | Hershey | Pennsylvania |
United States | Riley Children's Hospital | Indianapolis | Indiana |
United States | Loma Linda University Children's Hospital | Loma Linda | California |
United States | Children's Hospital of Los Angeles | Los Angeles | California |
United States | University of California, Los Angeles | Los Angeles | California |
United States | Kosair Children's Hospital | Louisville | Kentucky |
United States | LeBonheur Children's Hospital - University of Tennessee at Memphis | Memphis | Tennessee |
United States | Children's Hospital of Orange County | Orange | California |
United States | Children's Hospital of Philidelphia | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Washington University in St. Louis | Saint Louis | Missouri |
United States | Primary Children's Medical Center | Salt Lake City | Utah |
United States | University of Texas Health Sciences Center of San Antonio | San Antonio | Texas |
United States | University of California San Francisco | San Francisco | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Heart, Lung, and Blood Institute (NHLBI) |
United States, Canada, United Kingdom,
Meert KL, Donaldson A, Nadkarni V, Tieves KS, Schleien CL, Brilli RJ, Clark RS, Shaffner DH, Levy F, Statler K, Dalton HJ, van der Jagt EW, Hackbarth R, Pretzlaff R, Hernan L, Dean JM, Moler FW; Pediatric Emergency Care Applied Research Network. Multicent — View Citation
Moler FW, Donaldson AE, Meert K, Brilli RJ, Nadkarni V, Shaffner DH, Schleien CL, Clark RS, Dalton HJ, Statler K, Tieves KS, Hackbarth R, Pretzlaff R, van der Jagt EW, Pineda J, Hernan L, Dean JM; Pediatric Emergency Care Applied Research Network. Multice — View Citation
Moler FW, Meert K, Donaldson AE, Nadkarni V, Brilli RJ, Dalton HJ, Clark RS, Shaffner DH, Schleien CL, Statler K, Tieves KS, Hackbarth R, Pretzlaff R, van der Jagt EW, Levy F, Hernan L, Silverstein FS, Dean JM; Pediatric Emergency Care Applied Research Ne — View Citation
Moler FW, Silverstein FS, Holubkov R, Slomine BS, Christensen JR, Nadkarni VM, Meert KL, Browning B, Pemberton VL, Page K, Gildea MR, Scholefield BR, Shankaran S, Hutchison JS, Berger JT, Ofori-Amanfo G, Newth CJ, Topjian A, Bennett KS, Koch JD, Pham N, C — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Neurological Abnormality Scores (for Participants Who Survive) | Measured at Month 12 | ||
Primary | Survival With Good Neurobehavioral Outcome | Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest. Higher values of VABS-II represent a better outcome. | Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date. | |
Secondary | Survival | Survival at one year after cardiac arrest | Measured at one-year anniversary of cardiac arrest. | |
Secondary | Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest | Change in VABS-II score from baseline to one year, with death at 1 year treated as worst possible outcome, and lowest possible VABS-II score at one year (regardless of baseline VABS-II score) treated as the second worst possible outcome. Since higher levels of VABS-II represent a better outcome, a larger decline (large negative magnitude of change) in VABS-II score from baseline to one year represents a worse outcome. | Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date. | |
Secondary | Neuropsychological Scores (for Participants Who Survive) | Functioning, as assessed by the Mullen Early Learning Composite (for children age < 5 years 9 months) or by the 2-subset version of the Wechsler Abbreviated Scale of Intelligence (WASI). As these two function measures are scaled in the same fashion, the two age groups are combined. | Measured at Month 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06048068 -
Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events
|
N/A | |
Recruiting |
NCT05558228 -
Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
|
||
Completed |
NCT03685383 -
Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation
|
N/A | |
Completed |
NCT04584645 -
A Digital Flu Intervention for People With Cardiovascular Conditions
|
N/A | |
Completed |
NCT04619498 -
Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Withdrawn |
NCT02352350 -
Lactate in Cardiac Arrest
|
N/A | |
Completed |
NCT03024021 -
Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
|
||
Completed |
NCT02275234 -
Care After Resuscitation
|
||
Completed |
NCT02247947 -
Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome
|
||
Completed |
NCT01944605 -
Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest
|
N/A | |
Completed |
NCT01972087 -
Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest
|
N/A | |
Completed |
NCT01936597 -
Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage
|
N/A | |
Active, not recruiting |
NCT01239420 -
Norwegian Cardio-Respiratory Arrest Study
|
||
Completed |
NCT01191736 -
Ultra-Brief Versus Brief Hands Only CPR Video Training With and Without Psychomotor Skill Practice
|
N/A | |
Completed |
NCT00878644 -
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial
|
Phase 3 | |
Completed |
NCT00729794 -
Vasopressin, Epinephrine, and Steroids for Cardiac Arrest
|
Phase 3 | |
Recruiting |
NCT00441753 -
Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest
|
N/A | |
Completed |
NCT00347477 -
Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest
|
Phase 3 | |
Completed |
NCT00204217 -
Monitoring of Intubation and Ventilation During Resuscitation
|
Phase 2 |