Clinical trials: Normothermia
Intracerebral Hemorrhage
Systemic Normothermia in Intracerebral Hemorrhage (ICH)
Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group.
- Trial name
- SNICH (NCT02078037)
- Testing
- Arctic Sun cooling device, Standard of Care
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- The Cleveland Clinic
Kidney Transplant, DCD Kidney
NRP + ex Situ HMPO2 vs NRP Alone in DCD Kidney Transplantation
The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after…
- Trial name
- OxyPerf (NCT07779187)
- Testing
- Ex situ hypothermic oxygenated machine preservation
- Where
- 3 sites in Sweden
- Volunteers
- 214 people
- Sponsor
- Karolinska University Hospital
Lung Diseases
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end…
- Trial name
- NCT03641677
- Testing
- Centralized Lung Evaluation System, Lung Transplant
- Where
- 13 sites in United States
- Volunteers
- 174 people
- Sponsor
- Lung Bioengineering Inc.
Traumatic Brain Injury
Therapeutic Normothermia in TBI
This feasibility trial is the first step in testing the hypothesis that maintenance of normal body temperature, called therapeutic normothermia (TN), for 72 continuous hours in traumatic brain injury (TBI) patients can improve…
- Trial name
- MAMBA-FT (NCT06540768)
- Testing
- Therapeutic Normothermia Group
- Volunteers
- 50 people
- Sponsor
- London Health Sciences Centre
Glycocalyx, Liver Transplantation
Glycocalyx During Normothermic Machine Perfusion
An organ intended for transplantation is normally stored on ice (cold storage, CS) after explantation from the donor. During this storage process, damage to the endothelial glycocalyx occurs.
- Trial name
- NCT04764266
- Testing
- Heparansulfate and Syndecan 1
- Where
- Austria
- Volunteers
- 30 people
- Sponsor
- Medical University Innsbruck
Liver Disease (Alcoholic or Not), Transplantation
In-situ vs Ex-situ Liver Preservation
The goal of this Randomized Controlled Trial is to learn what machine preservation method is most clinically effective for liver transplantation (LTx) after donation after circulatory death (DCD).
- Trial name
- INSPIRE-NL (NCT07899853)
- Testing
- In-situ perfusion: aNRP, Ex-situ perfusion: DHOPE/DHOPE-COR-NMP
- Where
- 3 sites in Netherlands
- Volunteers
- 752 people
- Sponsor
- Leiden University Medical Center
Out-of-hospital Cardiac Arrest
Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest
ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence.
- Trial name
- TTM-2 (NCT02908308)
- Testing
- Targeted temperature management to 33°C, Standard care with early treatment of fever
- Where
- 60 sites in United States, Australia and 12 more
- Volunteers
- 1,900 people
- Sponsor
- Helsingborgs Hospital
Neonatal Encephalopathy, Newborn Asphyxia
Cooling in Mild Encephalopathy
The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish…
- Trial name
- COMET (NCT05889507)
- Testing
- Whole body hypothermia, Targeted normothermia, Supportive neonatal intensive care
- Where
- 39 sites in Italy, United Kingdom
- Volunteers
- 426 people
- Sponsor
- Imperial College London
Melanoma (Skin)
A Phase I Trial of Normothermic Isolated Limb Infusion (ILI) With Melphalan Plus Buthionine Sulfoximine (BSO) in Patients With Locally Advanced Malignant Melanoma
RATIONALE: Buthionine sulfoximine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells…
- Trial name
- NCT00661336
- Testing
- buthionine sulfoximine, melphalan, microarray analysis
- Where
- 2 sites in United States
- Sponsor
- Duke University
Knee Prosthesis
Effect of Normothermia Care Bundle in Knee Replacement Surgery
Osteoarthritis is a disease characterized by disruption of the integrity of articular cartilage as a result of erosion of articular cartilage.
- Trial name
- NCT06454877
- Testing
- active heating, pasive heating
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Istanbul Saglik Bilimleri University
Malignant Pleural Mesotheliomas (Mpm), Malignant Pleural Effusions (Mpe)
Phase I Evaluation of Immunotoxin LMB-100 Administered by Normothermic, Intrapleural Perfusion Following Cytoreductive Surgery in Participants With Pleural Mesotheliomas, or Pleural Effusions From Cancers Expressing Mesothelin
Background: Cancers that spread into the thin tissue lining your lungs (pleura) cause serious illness. They often recur when removed.
- Conditions
- Malignant Pleural Mesotheliomas (Mpm), Malignant Pleural Effusions (Mpe), Epithelial Tumors, Malignant, Pleural Effusions, Malignant
- Trial name
- NCT05375825
- Testing
- Cytoreductive surgery, LMB-100, Immunohistochemical Assay for Mesothelin
- Where
- United States
- Sponsor
- National Cancer Institute (NCI)
Liver Transplant Failure
Liver Graft Viability Assessment During Normothermic Regional Perfusion
With the increasing shortage of available donor organs, liver transplantation from donation after circulatory death (DCD) has been established in many countries to offer a therapeutic strategy for patients with end-stage liver…
- Trial name
- MAASTR3BOLOMIC (NCT05361044)
- Testing
- Blood samples Donnor
- Where
- 4 sites in France
- Volunteers
- 60 people
- Sponsor
- Hospices Civils de Lyon
Heart Arrest, Out-Of-Hospital, Hypoxia-Ischemia, Brain
Neuropsychological Outcome After Cardiac Arrest
This study is a sub-study to the large pragmatic Target Temperature Management 2 Trial (TTM2-trial, ClinicalTrials.gov Identifier: NCT02908308), assessing effectiveness of controlled hypothermia after out-of-hospital cardiac…
- Conditions
- Heart Arrest, Out-Of-Hospital, Hypoxia-Ischemia, Brain, Cognition Disorders, Psychological Distress
- Trial name
- NCT03543371
- Testing
- Neuropsychological assessment
- Where
- 8 sites in Denmark, Sweden and 1 more
- Volunteers
- 200 people
- Sponsor
- Region Skane
Lung Transplantation
SI-EVLP Study: STRESS INDEX in Lung Reconditioning
In order to minimize mechanical stress the investigators propose to implement EVLP procedure with a ventilation monitoring guided by the analysis of the Paw-t shape.
- Trial name
- NCT01729637
- Where
- Italy
- Volunteers
- 11 people
- Sponsor
- University of Turin, Italy
Normothermic Machine Perfusion (NMP) of Deceased Donor Kidneys
Registry Analysis of Deceased Donor Kidney Transplant Outcomes
This study uses existing transplant data obtained from a national public donor registry operated by the Organ Procurement and Transplant Network (OPTN) under Health Resources and Services Agency (HRSA) to evaluate outcomes…
- Trial name
- NCT07530991
- Where
- United States
- Volunteers
- 3,500 people
- Sponsor
- Chris Jaynes
Liver Transplantation
Viability Testing and Transplantation of Marginal Livers
This study is designed to determine if a rejected liver is viable using normothermic machine liver perfusion (NMLP). It aims to 1.
- Trial name
- VITTAL (NCT02740608)
- Testing
- OrganOx metra
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- University of Birmingham
Organ Transplantation, Liver Dysfunction
Normothermic Oxygenated Perfusion (NMP) Viability Testing Before Transplantation of Discarded Livers
Liver transplantation (LT) is a highly effective treatment for end-stage liver disease and early-stage primary liver cancer. As such, the demand for donor livers greatly exceeds supply; in 2021 in France, 12.9% of patients on the…
- Conditions
- Organ Transplantation, Liver Dysfunction, Liver Diseases
- Trial name
- TRANSPERF (NCT06950398)
- Testing
- NMP viability testing
- Where
- 6 sites in France
- Volunteers
- 99 people
- Sponsor
- Rennes University Hospital
Liver Transplant; Complications, Transplant; Failure, Liver
Liver Transplantation After ex Vivo Liver Perfusion
Today, it is difficult to predict liver function after transplantation and therefore livers where poor function is assumed (marginal livers) become discarded.
- Conditions
- Liver Transplant; Complications, Transplant; Failure, Liver, Transplant Dysfunction, Transplant; Complication, Rejection
- Trial name
- EVOLVE (NCT05951231)
- Testing
- Liver transplantation
- Volunteers
- 22 people
- Sponsor
- Oslo University Hospital
Heart Transplant Failure, Determination of Death
Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation
This is a prospective, pilot trial to evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System ("SherpaPak CTS") in transportation of cardiac allografts recovered from donors after circulatory…
- Conditions
- Heart Transplant Failure, Determination of Death, Outcomes Research, Extracorporeal Membrane Oxygenation
- Trial name
- NCT05038943
- Testing
- Paragonix SherpaPak Cardiac Transport System
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Nebraska
Liver Transplant Disorder
Viability Assessment Using FMN Measured in Perfusate and Bile During Normothermic Machine Perfusion
Discarded perfusate samples will be collected from donors after circulatory death (DCD) or donors after brain death (DBD) organs during the machine perfusion period prior to transplantation by the study team.
- Trial name
- NCT07315204
- Where
- United States
- Volunteers
- 850 people
- Sponsor
- The Cleveland Clinic