NCT03919474|CompletedDMC
Blood Markers in Adult Patients With Sudden Sensorineural Hearing Loss (SSNHL)
SSNHL
Markers of Microvascular Lesion in Adult Patients With Acquired Sudden Cochelo-vestibular Deficiency
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SSNHL
Markers of Microvascular Lesion in Adult Patients With Acquired Sudden Cochelo-vestibular Deficiency
Sponsor study identifier
observational
394
1 country
1
Study Start
January 2016
Actual (reported)Primary Completion
June 30, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)The roles of thrombophilia and cardiovascular risk factors in sudden sensorineural hearing loss (SSNHL) remain controversial. Cochlear micro-thrombosis has been hypothesized as a possible pathogenic mechanism of SSNHL. The objective was thus to measure the levels of markers of macrovascular thrombosis and microvascular risk factors
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
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.
January 2016
Actual (reported)April 2, 2019
Actual (reported)April 18, 2019
Actual (reported)June 30, 2019
Actual (reported)December 31, 2019
Actual (reported)change from Baseline of plasma serotonin at three months
plasma serotonin level (HPLC, frequent value \<15nM)
at three months and then once a year up to five years
change from Baseline of plasma homocystein at three months
plasma homocystein (HPLC, fequent value \<15 µM)
at three months and then once a year up to five years
change from Baseline serum of anticardiolipine antibody at three months
serum anticardiolipin antiboy (ELISA, frequent value \<10units)
at three months and then once a year up to five years
change from Baseline of hearing characteristics at three months
at three months and then once a year up to five years
follow up of microvascular biomarkers during patient follow up
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
unrelated adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic of our university hospital
HLariboisier otholaryngology clinic
Paris, 75010, France
Callebert J, Esteve JM, Herve P, Peoc'h K, Tournois C, Drouet L, Launay JM, Maroteaux L. Evidence for a control of plasma serotonin levels by 5-hydroxytryptamine(2B) receptors in mice. J Pharmacol Exp Ther. 2006 May;317(2):724-31. doi: 10.1124/jpet.105.098269. Epub 2006 Feb 3.
Brand T, Anderson GM. The measurement of platelet-poor plasma serotonin: a systematic review of prior reports and recommendations for improved analysis. Clin Chem. 2011 Oct;57(10):1376-86. doi: 10.1373/clinchem.2011.163824. Epub 2011 Aug 22.
venous peripheral blood
jean-marie Launay, PharmD, PhD
Hopital Lariboisière
394 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2019
First Posted
April 18, 2019
Study Start
January 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 30, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)Last Updated
February 10, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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