Hypothermia News - LARVOL Sigma

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15 Mechanisms of Action

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|||||||||| Trial completion, 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 --> Completed

|||||||||| Trial termination: Thermogard™ Efficacy Trial (clinicaltrials.gov) - Jul 21, 2013
P=N/A, N=9, Terminated, Sponsor: Brooke Army Medical Center
Not yet recruiting --> Completed Enrolling by invitation --> Terminated; Difficulty in obtaining surrogate consent on critically ill subjects.

|||||||||| Enrollment change: Thermogard™ Efficacy Trial (clinicaltrials.gov) - Jul 21, 2013
P=N/A, N=9, Terminated, Sponsor: Brooke Army Medical Center
Enrolling by invitation --> Terminated; Difficulty in obtaining surrogate consent on critically ill subjects. N=32 --> 9

|||||||||| New P1 trial, Surgery: Targeted Hypothermia During Cardiac Surgery (clinicaltrials.gov) - Jul 8, 2013
P1, N=20, Recruiting, Sponsor: NeuroSave Inc.

|||||||||| Trial completion: TTM: Target Temperature Management After Cardiac Arrest (clinicaltrials.gov) - Jul 7, 2013
P=N/A, N=950, Completed, Sponsor: Niklas Nielsen
N=32 --> 9 Active, not recruiting --> Completed

|||||||||| Trial withdrawal, MRI: Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE) (clinicaltrials.gov) - Jul 4, 2013
P=N/A, N=0, Withdrawn, Sponsor: Vanderbilt University
Active, not recruiting --> Completed Terminated --> Withdrawn

|||||||||| Trial completion: Changes of Body Temperature During Shoulder Arthroscopy (clinicaltrials.gov) - Jun 25, 2013
P=N/A, N=50, Completed, Sponsor: Gachon University Gil Medical Center
Terminated --> Withdrawn Not yet recruiting --> Completed

||||||||||  clonidine / Generic mfg.
New P1/2 trial:  Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia (clinicaltrials.gov) -  May 22, 2013
P1/2, N=30, Not yet recruiting,  Sponsor: Estelle B. Gauda, MD

|||||||||| Trial initiation date: Therapeutic Hypothermia After the Return of Spontaneous Circulation (clinicaltrials.gov) - May 14, 2013
P=N/A, N=46, Terminated, Sponsor: University of California, San Francisco
Not yet recruiting --> Completed Initiation date: Jun 2012 --> Mar 2013

|||||||||| Trial completion: THER5: Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section (clinicaltrials.gov) - May 10, 2013
P=N/A, N=40, Completed, Sponsor: University of Schleswig-Holstein
Initiation date: Jun 2012 --> Mar 2013 Recruiting --> Completed

|||||||||| Clinical: Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan (clinicaltrials.gov) - May 3, 2013
P=N/A, N=30, Recruiting, Sponsor: ZOLL Circulation, Inc., USA

|||||||||| Biomarker, Enrollment open: MARBLE: Magnetic Resonance Biomarkers in Neonatal Encephalopathy (clinicaltrials.gov) - Apr 18, 2013
P=N/A, N=120, Recruiting, Sponsor: Thayyil, Sudhin
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Trial completion: Effectiveness of Heat Donation Through the Head or Torso on Mild Hypothermic Rewarming (clinicaltrials.gov) - Apr 3, 2013
P=N/A, N=7, Completed, Sponsor: University of Manitoba
Not yet recruiting --> Recruiting Not yet recruiting --> Completed

|||||||||| Enrollment closed: CHILL-MI: Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction (clinicaltrials.gov) - Apr 3, 2013
P2/3, N=120, Active, not recruiting, Sponsor: Region Skane
Not yet recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Trial initiation date, Surgery: The Use of Thermal Suits as Preventing Hypothermia During Surgery (clinicaltrials.gov) - Apr 2, 2013
P4, N=100, Recruiting, Sponsor: Tampere University Hospital
Recruiting --> Active, not recruiting Initiation date: Apr 2012 --> Nov 2012

|||||||||| Enrollment open, Surgery: The Use of Thermal Suits as Preventing Hypothermia During Surgery (clinicaltrials.gov) - Apr 2, 2013
P4, N=100, Recruiting, Sponsor: Tampere University Hospital
Initiation date: Apr 2012 --> Nov 2012 Not yet recruiting --> Recruiting

||||||||||  midodrine hydrochloride / Generic mfg.
New P4 trial:  Body Temperature in Persons With Tetraplegia When Exposed to Cold (clinicaltrials.gov) -  Mar 31, 2013
P4, N=30, Recruiting,  Sponsor: James J. Peters Veterans Affairs Medical Center

|||||||||| Enrollment change: CoolCap Followup Study-Coordination of Participating Centers (clinicaltrials.gov) - Mar 6, 2013
P=N/A, N=62, Completed, Sponsor: University of Rochester
Not yet recruiting --> Recruiting N=140 --> 62

|||||||||| Trial completion: CoolCap Followup Study-Coordination of Participating Centers (clinicaltrials.gov) - Mar 6, 2013
P=N/A, N=62, Completed, Sponsor: University of Rochester
N=140 --> 62 Enrolling by invitation --> Completed

|||||||||| Enrollment closed: Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial (clinicaltrials.gov) - Feb 26, 2013
P3, N=350, Active, not recruiting, Sponsor: University of Michigan
Enrolling by invitation --> Completed Recruiting --> Active, not recruiting

|||||||||| Enrollment change: CoCaHYp: Cerebral Oxygenation in Cardiac Arrest and Hypothermia (clinicaltrials.gov) - Feb 21, 2013
P=N/A, N=94, Completed, Sponsor: Charite University, Berlin, Germany
Recruiting --> Active, not recruiting N=70 --> 94

||||||||||  midazolam hydrochloride / Generic mfg.
Enrollment open:  Initiation of Cooling by EMS to Promote Adoption of In-hospital Hypothermia in Cardiac Arrest Survivors (clinicaltrials.gov) -  Feb 21, 2013
P=N/A, N=900, Recruiting,  Sponsor: Sunnybrook Health Sciences Centre
N=70 --> 94 Available --> Recruiting

|||||||||| Trial completion: CoCaHYp: Cerebral Oxygenation in Cardiac Arrest and Hypothermia (clinicaltrials.gov) - Feb 21, 2013
P=N/A, N=94, Completed, Sponsor: Charite University, Berlin, Germany
Available --> Recruiting Recruiting --> Completed

|||||||||| Enrollment open, Surgery: THER-6: Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery (clinicaltrials.gov) - Feb 20, 2013
P=N/A, N=99, Recruiting, Sponsor: University of Schleswig-Holstein
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| New P2 trial: Therapeutic Hypothermia for Severe Acute Pancreatitis (clinicaltrials.gov) - Feb 18, 2013
P2, N=10, Recruiting, Sponsor: New York University School of Medicine

|||||||||| Trial initiation date: Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part II (clinicaltrials.gov) - Feb 7, 2013
P4, N=182, Recruiting, Sponsor: University of Alabama at Birmingham
Not yet recruiting --> Recruiting Initiation date: Jun 2012 --> Feb 2013

|||||||||| Trial completion: Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V (clinicaltrials.gov) - Feb 7, 2013
P4, N=275, Completed, Sponsor: University of Alabama at Birmingham
Initiation date: Jun 2012 --> Feb 2013 Recruiting --> Completed

|||||||||| Biomarker, Trial completion: HITUPPAC-BIO: Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest (clinicaltrials.gov) - Jan 28, 2013
P=N/A, N=244, Completed, Sponsor: University Hospital, Grenoble
Recruiting --> Completed Recruiting --> Completed

|||||||||| New P2/3 trial: HASTIER: Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization (clinicaltrials.gov) - Jan 27, 2013
P2/3, N=120, Recruiting, Sponsor: University of California, Los Angeles

||||||||||  melphalan / Generic mfg.
New P1 trial:  EF5 in Melanoma Patients (clinicaltrials.gov) -  Dec 17, 2012
P1, N=20, Recruiting,  Sponsor: Douglas Tyler

||||||||||  melphalan / Generic mfg.
Enrollment open:  EF5 in Melanoma Patients (clinicaltrials.gov) -  Dec 13, 2012
P1, N=20, Recruiting,  Sponsor: Douglas Tyler
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment change: Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest (clinicaltrials.gov) - Dec 3, 2012
P4, N=36, Completed, Sponsor: Hospital Universitario La Paz
Not yet recruiting --> Recruiting N=30 --> 36

|||||||||| Trial completion: Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest (clinicaltrials.gov) - Dec 3, 2012
P4, N=36, Completed, Sponsor: Hospital Universitario La Paz
N=30 --> 36 Active, not recruiting --> Completed

|||||||||| Clinical: Hypothermia Following Acute Spinal Cord Injury (clinicaltrials.gov) - Nov 28, 2012
P=N/A, N=100, Recruiting, Sponsor: University of Miami

||||||||||  Enbrel (etanercept) / Pfizer, Amgen
New P2 trial:  Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function (clinicaltrials.gov) -  Nov 19, 2012
P2, N=100, Recruiting,  Sponsor: Medical University of Warsaw

|||||||||| New P2 trial, Combination therapy: ReCCLAIM II: Reperfusion With Cooling in Cerebral Acute Ischemia II (clinicaltrials.gov) - Nov 18, 2012
P2, N=0, Withdrawn, Sponsor: Emory University

|||||||||| Surgery: Pre-warmed Intravenous Fluids and Monitored Anesthesia Care (clinicaltrials.gov) - Nov 5, 2012
P=N/A, N=50, Recruiting, Sponsor: Samsung Medical Center

||||||||||  rocuronium / Generic mfg.
New P3 trial:  Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest (clinicaltrials.gov) -  Oct 30, 2012
P3, N=60, Recruiting,  Sponsor: Medical University of Vienna

|||||||||| Trial completion, Surgery: Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery (clinicaltrials.gov) - Oct 22, 2012
P=N/A, N=200, Completed, Sponsor: University Hospital, Basel, Switzerland
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: Intraoperative Warming Comparison of Devices (clinicaltrials.gov) - Sep 24, 2012
P=N/A, N=42, Completed, Sponsor: University of South Florida
Recruiting --> Completed Recruiting --> Completed

|||||||||| Enrollment open, Surgery: Impact of Expanded Peri Operative Warming (clinicaltrials.gov) - Sep 23, 2012
P=N/A, N=100, Recruiting, Sponsor: Genesys Regional Medical Center
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Surgery: Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery (clinicaltrials.gov) - Sep 12, 2012
P=N/A, N=40, Completed, Sponsor: Northern State Medical University

|||||||||| Trial completion: ReCCLAIM: Reperfusion With Cooling in Cerebral Acute Ischemia (clinicaltrials.gov) - Sep 4, 2012
P1, N=20, Completed, Sponsor: Emory University
Not yet recruiting --> Recruiting Not yet recruiting --> Completed

|||||||||| Biomarker: Hypothermia During ECMO to Decrease Brain Injury (clinicaltrials.gov) - Aug 28, 2012
P=N/A, N=94, Recruiting, Sponsor: Sood, Beena G., MD, MS

|||||||||| Enrollment change, Surgery: Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients (clinicaltrials.gov) - Aug 21, 2012
P3, N=25, Completed, Sponsor: University of Michigan
Not yet recruiting --> Completed N=100 --> 25

|||||||||| Trial completion, Surgery: Cerebral Oximetry and Neurological Outcomes in Aortic Arch Surgery Patients (clinicaltrials.gov) - Aug 21, 2012
P3, N=25, Completed, Sponsor: University of Michigan
N=100 --> 25 Recruiting --> Completed

||||||||||  hydrocortisone / Generic mfg., methylprednisolone sodium succinate / Generic mfg.
Trial completion, Surgery:  Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery (clinicaltrials.gov) -  Aug 13, 2012
P=N/A, N=121, Completed,  Sponsor: Cedars-Sinai Medical Center
Recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Brain.Pad (iCOOL 3) (clinicaltrials.gov) - Aug 6, 2012
P2, N=20, Completed, Sponsor: University Hospital Heidelberg
Recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: Weaning Preterm Infants at 1500 Grams From Incubators (clinicaltrials.gov) - Jul 31, 2012
P=N/A, N=21, Completed, Sponsor: Tel-Aviv Sourasky Medical Center
Recruiting --> Completed Active, not recruiting --> Completed

|||||||||| New P2 trial: VELOCITY: Evaluation of Ultrafast Hypothermia Before Reperfusion in STEMI Patients (clinicaltrials.gov) - Jul 30, 2012
P2, N=60, Active, not recruiting, Sponsor: Velomedix, Inc.