Clinical trials: Normothermia
Hypothermia
Thermal Compression Device for Maintenance of Perioperative Normothermia
Getting cold (not maintaining normothermia) around surgery (perioperative period) leads to many negative outcomes for patients including increased wound complications, abnormal heart rhythms and increased blood loss.
- Trial name
- NCT02155400
- Testing
- Bair Hugger, Prototype / Experimental device
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Stanford University
Heart Transplantation, Perfusion
Heart Transplantation Utilizing NRP DCD
This is a prospective, observational, pilot trial to evaluate the feasibility of heart transplantation using normothermic regional perfusion (NRP) donation after donor circulatory death (DCD).
- Conditions
- Heart Transplantation, Perfusion, Transplant Recipients
- Trial name
- NCT05243914
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Arizona
Melanoma
Evaluate Safety/Tolerability Intra-Arterial Temozolomide in Patients w/Extremity Melanoma by Isolated Limb Infusion
The purpose of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment.
- Trial name
- NCT01127594
- Testing
- Temozolomide
- Where
- 3 sites in United States
- Volunteers
- 29 people
- Sponsor
- Douglas Tyler
Liver Transplantation
WP02 Continued Access Study
The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.
- Trial name
- NCT04862156
- Testing
- Normothermic Machine Perfusion (NMP)
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- OrganOx Ltd.
Liver Transplant
Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion (NMP) to resuscitate moderately steatotic livers for transplantation in patients.
- Trial name
- NCT06088758
- Testing
- Normothermic machine perfusion (NMP) of steatotic liver
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Massachusetts General Hospital
End Stage Liver DIsease
Comparison of Hypothermic Versus Normothermic Ex-vivo Preservation.
Study groups: The study is a multicenter (Pisa and Milan), prospective, randomized study comparing D-HOPE (HMP) vs NMP in DCD and ECD-DBD (extended criteria brain-dead donors).
- Trial name
- DCDNet (NCT04744389)
- Testing
- Hypothermic Machine Perfusion, Normothermic Machine Perfusion
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
Lung Disease
Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility
This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation.
- Trial name
- NCT02234128
- Testing
- Toronto EVLP System™
- Where
- 8 sites in United States
- Volunteers
- 118 people
- Sponsor
- Lung Bioengineering Inc.
Traumatic Brain Injury
Normothermia Protocol for Traumatic Brain Injury Patients
Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets) 1. Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury…
- Trial name
- NCT01354509
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medivance, Inc.
Neonatal Temperature; Kangaroo Mother Care
Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?
The aim of the present study is to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care (KMC).
- Trial name
- NCT02645526
- Testing
- Woolen cap
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University Hospital Padova
Surgical Site Infection, Ventral Hernia
Effect of Active Warming on Surgical Site Infections
This study evaluates the effect of active warming by maintaining the normothermia during abdominal surgical procedures. The investigators hypothesize that there is no difference in terms of preventing surgical site infections…
- Trial name
- NCT04187378
- Testing
- Surgical Underbody Blanket, Surgical access blanket
- Where
- Turkey (Türkiye)
- Volunteers
- 48 people
- Sponsor
- Istanbul University - Cerrahpasa
Hepatocellular Injury, Liver Transplant Disorder
Hypothermic Oxygenated (HOPE) Versus Normothermic Machine Perfusion (NMP) in Human Liver Transplantation
The common practice of conventional cold storage (CCS) organ preservation has changed little since the initial introduction of the original University of Wisconsin (UW) organ preservation solution in the late 1980s.
- Trial name
- HOPE-NMP (NCT04644744)
- Testing
- Hypothermic oxygenated perfusion (HOPE), Normothermic machine perfusion (NMP)
- Where
- 4 sites in Germany
- Volunteers
- 213 people
- Sponsor
- Charite University, Berlin, Germany
Liver Transplantation
Pilot Study to Assess Safety and Feasibility of Normothermic Machine Preservation In Human Liver Transplantation
Normothermic machine perfusion (NMP) preservation is a promising method to decrease the complication of marginal donor livers compared to cold storage (CS).
- Trial name
- NCT02515708
- Testing
- Normothermic Liver perfusion Device
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Cristiano Quintini
Hypothermia Following Anesthesia, Intraoperative Complications
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
During long operations on the abdomen, patients often get cold. Doctors call this perioperative hypothermia. Even a small drop in body temperature can cause problems, such as more bleeding, wound infection, and a longer stay in…
- Conditions
- Hypothermia Following Anesthesia, Intraoperative Complications, Body Temperature Changes, Anesthesia, General
- Trial name
- NCT07854704
- Testing
- Forced-air warming, Intravenous fluid warming, Unwarmed intravenous fluids
- Where
- Russia
- Volunteers
- 61 people
- Sponsor
- The Leningrad Regional Clinical Hospital
Ischemic Reperfusion Injury
Efficacy Evaluation of Normothermic Perfusion Machine Preservation in Liver Transplant Using Very Old Donors
The purpose of this study is to evaluate the impact of normothermic machine perfusion in liver transplantation using grafts of brain death donors older or equal than 70 years
- Trial name
- CEFEMA (NCT02940600)
- Testing
- Normothermic machine perfusion, Static cold storage
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
Liver Transplantation
WP01 - Normothermic Liver Preservation
A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.
- Trial name
- NCT02775162
- Testing
- Normothermic Machine Perfusion (NMP), Standard of Care (Ice)
- Where
- 15 sites in United States
- Volunteers
- 267 people
- Sponsor
- OrganOx Ltd.
Liver Transplantation
Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers
Orphan livers are organs that have been declined for clinical use by all centers due to their marginality. The current standard of care of liver preservation before transplant is cold storage.
- Trial name
- NCT03456284
- Testing
- Normothermic Liver perfusion
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The Cleveland Clinic
Liver Transplantation
Sequential Hypo- and Normo-thermic Perfusion to Preserve Extended Criteria Donor Livers for Transplantation
Hypothermic machine perfusion (HMP) has been shown to be beneficial to preserve extended criteria donor (ECD) livers for transplantation.
- Trial name
- NCT04023773
- Testing
- Liver Machine Perfusion (MP) device
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Koji Hashimoto
Stroke, Ischemic, Stroke Hemorrhagic
Transnasal Induction of Normothermia for Neurogenic Fever
The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Seizures, Metabolic Encephalopathy
- Trial name
- NCT06038513
- Testing
- Transnasal Thermal Regulating Device
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- CoolTech LLC
End Stage Liver Disease, Liver Diseases
Normothermic Liver Preservation Trial
This trial is to assess the safety and efficacy of normothermic machine perfusion (NMP) as an organ preservation method prior to transplantation using the OrganOx metra™ device.
- Trial name
- NCT03089840
- Testing
- OrganOx metra
- Where
- Canada
- Volunteers
- 106 people
- Sponsor
- University of Alberta
End-stage Liver Disease
Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation
This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation.
- Trial name
- NCT02478151
- Testing
- OrganOx Metra
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University Health Network, Toronto