Clinical trials: Targeted Temperature Management
Hypoxic Ischemic Encephalopathy
Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Selective head cooling or whole body hypothermia has become the standard of care for neonatal hypoxia-ischemia encephalopathy (HIE).
- Trial name
- DANCE (NCT01471015)
- Testing
- Darbepoetin alfa
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Utah
Hypoxic-Ischemic Encephalopathy
Holding, Stress, and Bonding During Therapeutic Hypothermia
Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period.
- Trial name
- NCT03079284
- Testing
- Holding during cooling
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Alexa Craig
Fever, Ischemic Stroke
Impact of Fever Prevention in Brain Injured Patients
This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients.
- Conditions
- Fever, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- Trial name
- INTREPID (NCT02996266)
- Testing
- Targeted Temperature Management, Standard Care
- Where
- 40 sites in United States, Australia and 4 more
- Volunteers
- 686 people
- Sponsor
- C. R. Bard
Cardiac Arrest
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial
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…
- Trial name
- THAPCA-OH (NCT00878644)
- Testing
- Therapeutic Hypothermia, Therapeutic Normothermia
- Where
- 34 sites in United States, Canada
- Volunteers
- 295 people
- Sponsor
- University of Michigan
Stroke, Acute
Reperfusion With Cooling in Cerebral Acute Ischemia
The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic…
- Trial name
- ReCCLAIM (NCT01585597)
- Testing
- Zoll- Coolgaurd 3000
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Emory University
Traumatic Brain Injury
Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device
The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with…
- Trial name
- NCT02420639
- Testing
- Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.
- Where
- Ukraine
- Volunteers
- 12 people
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Encephalopathy, Hypoxic-Ischemic
Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
This research is being done to find out the safety of the investigational study drug, Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE).
- Trial name
- HIE (NCT01862250)
- Testing
- Clonidine (Duraclon®)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Johns Hopkins University
Infant, Newborn, Asphyxia Neonatorum
Optimising Newborn Nutrition During Therapeutic Hypothermia.
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia.
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition
- Trial name
- NCT03278847
- Testing
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia, Received parenteral nutrition during therapeutic hypothermia
- Where
- 2 sites in United Kingdom
- Volunteers
- 6,030 people
- Sponsor
- Imperial College London
Postoperative Pain, Shoulder Pain
Compression and Cold Therapy on the Post-Operative Shoulder
The purpose of this study is to evaluate and compare clinical post-operative outcomes for patients using active cooling and compression device and those using ice bags and elastic wrap after acromioplasty or arthroscopic rotator…
- Trial name
- NCT00703729
- Testing
- Cold Compression (CC), Ice Wrap (IW)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- University of Colorado, Denver
Cardiac Arrest, Postresuscitation Syndrome
Antiplatelet Therapy After Cardiac Arrest
There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after cardiac arrest as in normothermic patients.
- Conditions
- Cardiac Arrest, Postresuscitation Syndrome, Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)
- Trial name
- NCT02224274
- Testing
- Clopidogrel, Ticagrelor
- Where
- Slovenia
- Volunteers
- 57 people
- Sponsor
- University Medical Centre Ljubljana
Acute Myocardial Infarction
COOL AMI EU Pivotal Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)
The objective of this trial is to evaluate the safety and effectiveness of therapeutic hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction…
- Trial name
- NCT03173313
- Testing
- Intravascular permissive hypothermia as an adjunct to PCI
- Where
- Slovenia
- Volunteers
- 111 people
- Sponsor
- ZOLL Circulation, Inc., USA
Post-Op Complication
Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
This is an unblinded, single center, randomized study of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming intervention or to the standard of care (strict…
- Trial name
- NCT03036072
- Testing
- Strict normothermia, Delayed Rewarming
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Alexa Craig
Neonatal Encephalopathy
CoolCap Followup Study-Coordination of Participating Centers
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial.
- Trial name
- NCT00581581
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Rochester