NCT01102153|Completed
Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy After Survived Sudden Cardiac Death
NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death
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NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death
Sponsor study identifier
observational
108
1 country
2
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Sudden cardiac death remains one of the major leading causes of death. Therapeutic hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after cardiac arrest. To assess the efficiency of different cooling methods and further improve these methods, the investigators collected blood samples to measure the neuron specific enolase (NSE) in patients treated with invasive cooling as compared to patients treated with non-invasive cooling.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 2010
Actual (reported)January 2010
Actual (reported)February 8, 2010
Actual (reported)April 13, 2010
Actual (reported)neuron specific enolase (NSE) as a parameter for cerebral damage
Blood samples were collected at predefined time-points within 72 hours to measure neuron specific enolase.
72 hours
neurologic outcome
6 months
time to overall survival
one year
invasive cooling
non-invasive (surface) cooling
invasive cooling via femoral ICY-catheter
non-invasive surface cooling by saline-cooled thermo-vest
Patients who survived sudden cardiac arrest and where treated with cooling-therapies
University of Leipzig, Heart Center, Cardiology
Leipzig, 04289, Germany
University of Leipzig, Heart Center, Cardiology
Leipzig, Germany
Sulaj M, Saniova B, Drobna E, Schudichova J. Serum neuron specific enolase and malondialdehyde in patients after out-of-hospital cardiac arrest. Cell Mol Neurobiol. 2009 Sep;29(6-7):807-10. doi: 10.1007/s10571-009-9361-y. Epub 2009 Feb 25.
Shinozaki K, Oda S, Sadahiro T, Nakamura M, Hirayama Y, Abe R, Tateishi Y, Hattori N, Shimada T, Hirasawa H. S-100B and neuron-specific enolase as predictors of neurological outcome in patients after cardiac arrest and return of spontaneous circulation: a systematic review. Crit Care. 2009;13(4):R121. doi: 10.1186/cc7973. Epub 2009 Jul 22.
Holger Thiele, Associate Professor
Study Chair
Undine Pittl, MD
Study Sub-Investigator
Alexandra Schratter, MD
Study Sub-Investigator
108 participants (actual enrollment reported by the registry).
First Submitted
February 8, 2010
First Posted
April 13, 2010
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Haemostasis and Therapeutic Hypothermia
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Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
April 13, 2010
Record last verified: 2010-01
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Source: ClinicalTrials.gov.
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