Hypothermia News - LARVOL Sigma

Hypothermia

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15 Mechanisms of Action

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|||||||||| Clinical data, Trial termination: Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects (clinicaltrials.gov) - Jun 1, 2014
P2, N=6, Terminated, Sponsor: Department of Defense
Recruiting --> Terminated; Low accrual

|||||||||| Clinical data, Enrollment change: Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects (clinicaltrials.gov) - Jun 1, 2014
P2, N=6, Terminated, Sponsor: Department of Defense
Recruiting --> Terminated; Low accrual N=105 --> 6

|||||||||| Trial primary completion date: MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE) (clinicaltrials.gov) - May 27, 2014
P=N/A, N=10, Recruiting, Sponsor: Vanderbilt University
N=105 --> 6 Trial primary completion date: May 2013 --> May 2018

|||||||||| Trial completion date: MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE) (clinicaltrials.gov) - May 27, 2014
P=N/A, N=10, Recruiting, Sponsor: Vanderbilt University
Trial primary completion date: May 2013 --> May 2018 Trial completion date: May 2013 --> Jun 2018

|||||||||| Trial primary completion date: SPARC: The Strategies for Post Arrest Resuscitation and Care Network (clinicaltrials.gov) - May 13, 2014
P=N/A, N=43, Active, not recruiting, Sponsor: St. Michael's Hospital, Toronto
Trial completion date: May 2013 --> Jun 2018 Trial primary completion date: Jan 2010 --> Jan 2012

|||||||||| Trial completion date: SPARC: The Strategies for Post Arrest Resuscitation and Care Network (clinicaltrials.gov) - May 13, 2014
P=N/A, N=43, Active, not recruiting, Sponsor: St. Michael's Hospital, Toronto
Trial primary completion date: Jan 2010 --> Jan 2012 Trial completion date: Dec 2010 --> Dec 2015

|||||||||| Enrollment closed: SPARC: The Strategies for Post Arrest Resuscitation and Care Network (clinicaltrials.gov) - May 13, 2014
P=N/A, N=43, Active, not recruiting, Sponsor: St. Michael's Hospital, Toronto
Trial completion date: Dec 2010 --> Dec 2015 Enrolling by invitation --> Active, not recruiting

|||||||||| Preclinical, Trial termination: COOLDonor: Cooling to Optimize Organ Life in Donor Study (clinicaltrials.gov) - May 4, 2014
P2, N=4, Terminated, Sponsor: University of Pittsburgh
Enrolling by invitation --> Active, not recruiting Recruiting --> Terminated; Lack of funding and other logistic reasons

|||||||||| Preclinical, Enrollment change: COOLDonor: Cooling to Optimize Organ Life in Donor Study (clinicaltrials.gov) - May 4, 2014
P2, N=4, Terminated, Sponsor: University of Pittsburgh
Recruiting --> Terminated; Lack of funding and other logistic reasons N=60 --> 4

|||||||||| Trial primary completion date: 10-015: Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation (clinicaltrials.gov) - Apr 28, 2014
P2, N=30, Recruiting, Sponsor: RWTH Aachen University
N=60 --> 4 Trial primary completion date: Dec 2013 --> Dec 2014

|||||||||| Trial completion date: 10-015: Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation (clinicaltrials.gov) - Apr 28, 2014
P2, N=30, Recruiting, Sponsor: RWTH Aachen University
Trial primary completion date: Dec 2013 --> Dec 2014 Trial completion date: Dec 2013 --> Dec 2014

|||||||||| Enrollment change: 10-015: Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation (clinicaltrials.gov) - Apr 28, 2014
P2, N=30, Recruiting, Sponsor: RWTH Aachen University
Trial completion date: Dec 2013 --> Dec 2014 N=100 --> 30

|||||||||| Trial suspension: HYBERNATUS: Evaluation of Therapeutic Hypothermia in Convulsive Status EPILEPTICUS in Adults in Intensive Care (clinicaltrials.gov) - Apr 21, 2014
P3, N=270, Suspended, Sponsor: Assistance Publique - Hôpitaux de Paris
N=100 --> 30 Recruiting --> Suspended

|||||||||| Trial initiation date: Optimal Positioning of Nasopharyngeal Temperature Probes: A Prospective Cohort Study (clinicaltrials.gov) - Apr 21, 2014
P=N/A, N=50, Not yet recruiting, Sponsor: The Cleveland Clinic
Recruiting --> Suspended Initiation date: Jan 2014 --> Apr 2014

|||||||||| Trial initiation date: CARBOXHYD: Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth (clinicaltrials.gov) - Apr 17, 2014
P=N/A, N=70, Recruiting, Sponsor: Centre Hospitalier Universitaire de Nice
Initiation date: Jan 2014 --> Apr 2014 Initiation date: Feb 2014 --> Mar 2014

|||||||||| Enrollment open: CARBOXHYD: Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth (clinicaltrials.gov) - Apr 17, 2014
P=N/A, N=70, Recruiting, Sponsor: Centre Hospitalier Universitaire de Nice
Initiation date: Feb 2014 --> Mar 2014 Not yet recruiting --> Recruiting

|||||||||| Trial completion: Sequential Compression Device on Body Temperature (clinicaltrials.gov) - Apr 2, 2014
P=N/A, N=40, Completed, Sponsor: Gachon University Gil Medical Center
Not yet recruiting --> Recruiting Recruiting --> Completed

|||||||||| Enrollment open: HASTIER: Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization (clinicaltrials.gov) - Mar 17, 2014
P2/3, N=120, Recruiting, Sponsor: University of California, Los Angeles
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Head-to-Head: Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia (clinicaltrials.gov) - Mar 3, 2014
P=N/A, N=60, Recruiting, Sponsor: Molnlycke Health Care AB

|||||||||| New P1/2 trial: Melatonin for Neuroprotection Following Perinatal Asphyxia (clinicaltrials.gov) - Feb 23, 2014
P1/2, N=45, Completed, Sponsor: Tanta University

|||||||||| Enrollment closed: VELOCITY: Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients (clinicaltrials.gov) - Feb 19, 2014
P2, N=60, Active, not recruiting, Sponsor: Velomedix, Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

|||||||||| Trial termination: Therapeutic Hypothermia After the Return of Spontaneous Circulation (clinicaltrials.gov) - Feb 11, 2014
P=N/A, N=46, Terminated, Sponsor: University of California, San Francisco
Recruiting --> Active, not recruiting Recruiting --> Terminated; A similar study was recently published with definitive results.

|||||||||| Enrollment change: Therapeutic Hypothermia After the Return of Spontaneous Circulation (clinicaltrials.gov) - Feb 11, 2014
P=N/A, N=46, Terminated, Sponsor: University of California, San Francisco
Recruiting --> Terminated; A similar study was recently published with definitive results. N=400 --> 46

|||||||||| Trial initiation date, Surgery: Targeted Hypothermia During Cardiac Surgery (clinicaltrials.gov) - Feb 10, 2014
P1, N=20, Recruiting, Sponsor: NeuroSave Inc.
N=400 --> 46 Initiation date: Aug 2013 --> Feb 2014

|||||||||| Enrollment open, Surgery: Targeted Hypothermia During Cardiac Surgery (clinicaltrials.gov) - Feb 10, 2014
P1, N=20, Recruiting, Sponsor: NeuroSave Inc.
Initiation date: Aug 2013 --> Feb 2014 Not yet recruiting --> Recruiting

||||||||||  cefazolin / Generic mfg.
Trial completion, Surgery:  Surgical Site Infection Study (clinicaltrials.gov) -  Feb 6, 2014
P=N/A, N=14, Completed,  Sponsor: Children's Hospital of Philadelphia
Not yet recruiting --> Recruiting Enrolling by invitation --> Completed

||||||||||  rocuronium / Generic mfg.
Enrollment closed:  Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest (clinicaltrials.gov) -  Feb 3, 2014
P=N/A, N=40, Active, not recruiting,  Sponsor: Medical University of Vienna
Enrolling by invitation --> Completed Recruiting --> Active, not recruiting

|||||||||| Clinical: Optimal Positioning of Nasopharyngeal Temperature Probes: A Prospective Cohort Study (clinicaltrials.gov) - Jan 21, 2014
P=N/A, N=50, Not yet recruiting, Sponsor: The Cleveland Clinic

|||||||||| Enrollment open: Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm (clinicaltrials.gov) - Jan 12, 2014
P=N/A, N=584, Recruiting, Sponsor: Centre Hospitalier Departemental Vendee
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

|||||||||| New P1 trial, Surgery: Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia (clinicaltrials.gov) - Jan 12, 2014
P1, N=30, Completed, Sponsor: University of Malaya

|||||||||| Trial completion: Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring (clinicaltrials.gov) - Jan 6, 2014
P=N/A, N=120, Completed, Sponsor: University of Schleswig-Holstein
Not yet recruiting --> Recruiting Not yet recruiting --> Completed

|||||||||| Trial completion: Discrete Hypothermia in the Management of Traumatic Brain Injury (clinicaltrials.gov) - Dec 18, 2013
P3, N=25, Completed, Sponsor: Emory University
Not yet recruiting --> Completed Active, not recruiting --> Completed

||||||||||  topiramate / Generic mfg.
Trial completion:  NeoNATI: Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia (clinicaltrials.gov) -  Dec 11, 2013
P2, N=64, Completed,  Sponsor: Azienda Ospedaliero, Universitaria Meyer
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: Cognitive Impairment Following Cardiac Arrest and Target Temperature Management (clinicaltrials.gov) - Dec 3, 2013
P=N/A, N=287, Completed, Sponsor: Region Skane
Recruiting --> Completed Recruiting --> Completed

||||||||||  aspirin / Generic mfg., desmopressin / Generic mfg.
Trial completion:  Effect of Aspirin, Hemodilution and Desmopressin on Platelet Dysfunction (clinicaltrials.gov) -  Nov 13, 2013
P=N/A, N=60, Completed,  Sponsor: The University of Hong Kong
Recruiting --> Completed Not yet recruiting --> Completed

|||||||||| Trial withdrawal, Combination therapy: ReCCLAIM II: Reperfusion With Cooling in Cerebral Acute Ischemia II (clinicaltrials.gov) - Nov 9, 2013
P2, N=0, Withdrawn, Sponsor: Emory University
Not yet recruiting --> Completed Not yet recruiting --> Withdrawn

|||||||||| Enrollment change, Combination therapy: ReCCLAIM II: Reperfusion With Cooling in Cerebral Acute Ischemia II (clinicaltrials.gov) - Nov 9, 2013
P2, N=0, Withdrawn, Sponsor: Emory University
Not yet recruiting --> Withdrawn N=85 --> 0

|||||||||| Trial completion: Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest (clinicaltrials.gov) - Oct 30, 2013
P2/3, N=1359, Completed, Sponsor: University of Washington
N=85 --> 0 Active, not recruiting --> Completed

|||||||||| Enrollment change, Surgery: Normothermia Versus Hypothermia for Valvular Surgery Patients (clinicaltrials.gov) - Oct 29, 2013
P=N/A, N=140, Completed, Sponsor: Meshalkin Research Institute of Pathology of Circulation
Active, not recruiting --> Completed N=500 --> 140

|||||||||| Trial completion, Surgery: Normothermia Versus Hypothermia for Valvular Surgery Patients (clinicaltrials.gov) - Oct 29, 2013
P=N/A, N=140, Completed, Sponsor: Meshalkin Research Institute of Pathology of Circulation
N=500 --> 140 Recruiting --> Completed

|||||||||| Enrollment closed: The Effect of Therapeutic Hypothermia on Deceased Donor Renal Graft Outcomes - a Randomized Controlled Trial From the Region 5 Donor Management Goals Workgroup (clinicaltrials.gov) - Oct 17, 2013
P=N/A, N=500, Active, not recruiting, Sponsor: University of California, San Francisco
Recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  Bridion (sugammadex) / Merck (MSD)
New P4 trial:  Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex (clinicaltrials.gov) -  Oct 16, 2013
P4, N=60, Recruiting,  Sponsor: MSD Korea Ltd.

|||||||||| Trial completion: California Transport Cooling Trial (clinicaltrials.gov) - Oct 15, 2013
P=N/A, N=100, Completed, Sponsor: Stanford University
Recruiting --> Active, not recruiting Recruiting --> Completed

|||||||||| Enrollment closed: Hypothermia in the Trauma Patient - When do Trauma Patients Get Cold? (clinicaltrials.gov) - Oct 7, 2013
P=N/A, N=60, Active, not recruiting, Sponsor: Norwegian University of Science and Technology
Recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Trial initiation date: TTH48: Time-differentiated Therapeutic Hypothermia (clinicaltrials.gov) - Sep 12, 2013
P=N/A, N=340, Recruiting, Sponsor: University of Aarhus
Recruiting --> Active, not recruiting Initiation date: Oct 2012 --> Jan 2013

|||||||||| Enrollment open: TTH48: Time-differentiated Therapeutic Hypothermia (clinicaltrials.gov) - Sep 12, 2013
P=N/A, N=340, Recruiting, Sponsor: University of Aarhus
Initiation date: Oct 2012 --> Jan 2013 Not yet recruiting --> Recruiting

|||||||||| Enrollment change: Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates (clinicaltrials.gov) - Aug 18, 2013
P4, N=106, Completed, Sponsor: University of Alabama at Birmingham
Not yet recruiting --> Recruiting N=200 --> 106

|||||||||| Trial completion: Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates (clinicaltrials.gov) - Aug 18, 2013
P4, N=106, Completed, Sponsor: University of Alabama at Birmingham
N=200 --> 106 Active, not recruiting --> Completed

|||||||||| Enrollment open: An Epidemiology Survey on the Incidence of Perioperative Hypothermia (clinicaltrials.gov) - Aug 4, 2013
P=N/A, N=800, Recruiting, Sponsor: Peking Union Medical College Hospital
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment change, Surgery: Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest (clinicaltrials.gov) - Jul 23, 2013
P4, N=66, Completed, Sponsor: Yonsei University
Not yet recruiting --> Recruiting N=90 --> 66