Clinical trials: Hypothermia
Heart Failure
HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.
The purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport System.
- Trial name
- HOPE@Heart (NCT06485596)
- Testing
- XVIVO Heart Assist Transport System
- Where
- 4 sites in Belgium, Netherlands
- Volunteers
- 40 people
- Sponsor
- XVIVO Perfusion
Acute Myocardial Infarction
COOL-AMI EU Case Series Clinical Study
A single-center, prospective case series clinical study consecutively enrolling up to 10 patients with expected duration of 12 months or less.
- Trial name
- NCT02070913
- Where
- 23 sites in Czechia, Estonia and 6 more
- Volunteers
- 352 people
- Sponsor
- ZOLL Circulation, Inc., USA
Cardiac Arrest
Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients
The primary objectives of this study are to determine the safety and feasibility of inducing mild hypothermia using a non-invasive thermoregulatory device, the Medivance Arctic Sun Temperature Management System, in patients…
- Trial name
- NCT00282373
- Testing
- mild hypothermia
- Where
- 6 sites in United States
- Volunteers
- 64 people
- Sponsor
- Medivance, Inc.
Cardiac Arrest
Esophageal Temperature Management After Cardiac Arrest
To control patient's body temperature remains of major importance especially after cardiac arrest (CA). Therapeutic hypothermia (TH) targeted to 32-34°C is now recommended for most unconscious CA patients.
- Trial name
- THE-COOL (NCT02327871)
- Testing
- Esophageal cooling device (and usual standard procedure)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- IST cardiology
Hypothermia, Complications
Impact of Expanded Peri Operative Warming
The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.
- Trial name
- NCT01649596
- Testing
- Warming Gown, Standard of care warming
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Ascension Health
Noise Exposure, Noise-induced Hearing Loss
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1.
- Conditions
- Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect, Mild Therapeutic Hypothermia
- Trial name
- NCT06729632
- Testing
- Cold pack-delivered mild therapeutic hypothermia
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Restorear Devices LLC
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
Cardiac Arrest
Antioxidant and NMDA Receptor Blocker Wins Anoxic Brain Damage of KorEa OHCA Patients
This study aims to investigate the efficacy and safety of Neu2000KWL, a neuroprotectant, in patients resuscitated from out-of-hospital cardiac arrest and receiving therapeutic hypothermia.
- Trial name
- AWAKE (NCT03651557)
- Testing
- Neu2000KWL High-dose group, Neu2000KWL Low-dose group
- Where
- 6 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- GNT Pharma
Tinnitus, Tinnitus, Subjective
Noninvasive Therapy for Tinnitus
The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of…
- Trial name
- NCT07071480
- Testing
- Cold pack-delivered mild therapeutic hypothermia
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Restorear Devices LLC
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
Cochlear Implants, Cochlear Implantation
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1.
- Conditions
- Cochlear Implants, Cochlear Implantation, Hearing Loss
- Trial name
- NCT06375278
- Testing
- Intra-Ear Canal Cooling Catheter
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Restorear Devices LLC
End Stage Liver DIsease, Liver Failure
VitaSmart HOPE System: Bridge to HOPE Registry
This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions.
- Trial name
- NCT07578441
- Testing
- hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Bridge to Life Ltd.
Total Aortic Arch Replacement
Near-Infrared Spectroscopy Comparison Study
The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS…
- Trial name
- NCT01352260
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Nonin Medical, Inc
Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress
Evaluation of In-Vitro Cryo Therapeutic Protocols on Human Cell Samples (TWH-CRYO-001)
This laboratory-based study evaluates the effects of controlled cryogenic preservation on human cell samples using Truway Health's in-vitro cryo therapeutic methodology.
- Conditions
- Cellular Injury and Post-Cryogenic Recovery, Cryogenic Cellular Stress, Cold-Induced Cellular Injury, Thermal Injury Response
- Trial name
- CRYO-IVT (NCT07321028)
- Testing
- Standard Laboratory Cryopreservation Procedure, Enhanced Laboratory Cryopreservation Procedure, Normothermic Cell Culture Control
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Truway Health, Inc.
Hypothermia; Anesthesia
enFlow IV Fluid and Blood Warming System
This study is part of a post-market clinical follow-up (PMCF). The purpose of this study is to verify in a routine clinical environment with a number of caregivers and subjects that the enFlow performs as intended when used as an…
- Trial name
- NCT04709627
- Testing
- enFlow IV Fluid and Blood Warming System
- Where
- 2 sites in Finland
- Volunteers
- 50 people
- Sponsor
- Vyaire Medical
Severe Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic Encephalopathy
Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy
The purpose of this study is to assess whether the addition of a drug such as Magnesium sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated at birth provides additional benefit to the…
- Trial name
- MagCool (NCT01646619)
- Testing
- Magnesium Sulphate
- Where
- 7 sites in Egypt, Malaysia and 4 more
- Volunteers
- 300 people
- Sponsor
- Sajjad Rahman
Cardiac Arrest
Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan
A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac arrest, post-return of spontaneous circulation (ROSC)…
- Trial name
- NCT01847482
- Testing
- ZOLL Intravascular Temperature Management System (IVTM)
- Where
- 10 sites in Japan
- Volunteers
- 26 people
- Sponsor
- ZOLL Circulation, Inc., USA
Aortic Arch Surgery
Near Infrared Spectroscopy (NIRS)
This study is designed to assess the feasibility of evaluating cerebral saturation during critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral Perfusion.
- Trial name
- NCT01429324
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Nonin Medical, Inc
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 22 sites in United States
- Volunteers
- 173 people
- Sponsor
- ReAlta Life Sciences, Inc.
Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain.
- Trial name
- NCT00383305
- Testing
- Cool-Cap
- Where
- 27 sites in United States, Canada and 2 more
- Volunteers
- 235 people
- Sponsor
- Olympic Medical