6 completed, 4 unknown, 1 recruiting, 1 terminated. 6 Not applicable, 5 Phase 2, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 6 | Completed 3, Unknown 2, Terminated 1 |
| Phase 2 | 5 | Completed 3, Unknown 1, Withdrawn 1 |
| Phase 1 | 2 | Completed 1, Unknown 1 |
Follow Normothermia: new trials by email Literature Review of Normothermia trials Research Report on Normothermia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Cool Prime Comparative Effectiveness Study for Mild HIE Normothermia, Whole body therapeutic hypothermia - Mild Hypoxic Ischemic Encephalopathy of Newborn | Recruiting | University of Texas Southwestern Medical Center | 460 | 2023-07-19 | 2026-09-25 | |
| Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation Moderate Hypothermia, Normothermia - ARDS, Human, Extracorporeal Membrane Oxygenation Complication | Not applicable | Unknown | Central Hospital, Nancy, France | 30 | 2022-09-01 | 2022-04-01 |
| TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy Therapeutic Hypothermia, Normothermia - Hypoxic-Ischemic Encephalopathy Mild, Neonatal Encephalopathy | Not applicable | Unknown | Stanford University | 68 | 2020-05-01 | 2020-03-18 |
| Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB) Premedication visit, Preoperative period, Postoperative period - Coronary Artery Disease, Coronary Stenosis | Unknown | Silesian University of Medicine | 100 | 2019-05-03 | 2019-05-20 | |
| Mild Hypothermia and Acute Kidney Injury in Liver Transplantation Esophageal cooling/warming device, Mild hypothermia, Normothermia - Cirrhosis, End Stage Liver Disease | Not applicable | Terminated | University of California, San Francisco | 175 | 2018-07-07 | 2025-05-16 |
| Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function Procedure control: normothermia, Procedure active - Organ Donor, Brain Death | Not applicable | Completed | Nantes University Hospital | 532 | 2017-11-08 | 2026-09-14 |
| REperfusion With Cooling in CerebraL Acute IscheMia II Normothermia, Mild hypothermia, Trevo Pro Retriever (Stryker Corp.) - Ischemic Stroke, Hypothermia | Phase 2 | Withdrawn | WellStar Health System | 2016-02-01 | 2016-02-17 | |
| Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm Targeted controlled temperature between 32.5 and 33.5°C, Targeted controlled temperature between 36.5 and 37.5°C - Cardiac Arrest | Not applicable | Completed | Centre Hospitalier Departemental Vendee | 584 | 2014-01-26 | 2019-01-16 |
| Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury Long-term mild hypothermia, Normothermia - Brain Injuries, Craniocerebral Trauma | Not applicable | Completed | RenJi Hospital | 312 | 2013-11-12 | 2026-08-13 |
| Safety and Feasibility Study of Targeted Temperature Management After ICH Normothermia, Hypothermia - Intracerebral Hemorrhage | Phase 1 / Phase 2 | Unknown | Thomas Jefferson University | 50 | 2013-01-01 | 2015-08-05 |
| Preoperative Hyperthermia in Major Abdominal Surgery Patients Normothermia, Hyperthermia - Colon Cancer | Phase 1 / Phase 2 | Completed | Medical University of Vienna | 20 | 2009-04-01 | 2016-01-21 |
| Hypothermia for Cardiac Arrest in Paediatrics Normothermia, Hypothermia - Cardiac Arrest | Phase 2 | Completed | The Hospital for Sick Children | 38 | 2005-01-01 | 2021-07-14 |
| Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy hypothermia, normothermia - Neonatal Asphyxial Encephalopathy, Hypoxic Ischemic Encephalopathy | Phase 2 | Completed | Medical University of South Carolina | 65 | 1999-06-01 | 2016-07-11 |
Hypothermia (5) · Brain Ischemia (2) · Heart Arrest (2) · Hypoxia-Ischemia, Brain (2) · Acute Kidney Injury (1) · Body Temperature Changes (1) · Brain Death (1) · Brain Diseases (1) · Brain Infarction (1) · Brain Injuries (1) · Brain Injuries, Traumatic (1) · Carcinoma, Hepatocellular (1) · Cardiovascular Diseases (1) · Central Nervous System Diseases (1) · Cerebral Hemorrhage (1)
Central Hospital, Nancy, France (1) · Centre Hospitalier Departemental Vendee (1) · Medical University of South Carolina (1) · Medical University of Vienna (1) · Nantes University Hospital (1) · RenJi Hospital (1) · Silesian University of Medicine (1) · Stanford University (1) · The Hospital for Sick Children (1) · Thomas Jefferson University (1) · University of California, San Francisco (1) · University of Texas Southwestern Medical Center (1) · WellStar Health System (1)
United States (5) · France (2) · Austria (1) · Canada (1) · China (1) · Guadeloupe (1) · New Zealand (1) · Poland (1) · United Kingdom (1)
Dorothea D Jenkins, MD (1) · Ewa Kucewicz-Czech (1) · Fred Rincon, MD, MSc (1) · Jamie Hutchison, MD (1) · Jean Baptiste Lascarrou, MD (1) · Jiyao Jiang, MD, PhD (1) · Lina Chalak, MD (1) · Michael P Bokoch, MD, PhD (1) · Oliver Kimberger, M.D. (1) · Rishi Gupta, MD (1) · Sonia Bonifacio, MD (1)
PMID 15607598, PMID 15607599, PMID 22805873, PMID 23584469, PMID 23897243, PMID 25447805, PMID 25882712, PMID 25923575, PMID 31577396, PMID 33681741, PMID 34854918, PMID 35351701, PMID 35999380, PMID 36251223, PMID 38041177, PMID 38876137
R01NS038062 (1)