Clinical trial NCT03919474: Blood Markers in Adult Patients With Sudden Sensorineural Hearing Loss (SSNHL)
Official title: Markers of Microvascular Lesion in Adult Patients With Acquired Sudden Cochelo-vestibular Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic SSNHL
Age Over 18
Keywords: sudden hearing loss,
SSNHL
serotonin
homocystein
antiphospholipid syndrom
thrombophilia
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: unrelated adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic of our university hospital

Brief summary: 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

Detailed description: To recruit adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic of our university hospital starting June 2016 and prospectively until december 31th 2018.

Plasma sampling and biomarkers quantification : After a 48-hours diet excluding serotonin- and tryptophan-rich food, fasting blood samples were collected into vacuum tubes containing 109 mM sodium citrate (Becton-Dickinson, Le Pont de Claix, France) with a 9:1 blood-to-anticoagulant ratio. After removing 0.5 mL of whole blood for serotonin measurements, the remainder was centrifuged at 1,000 x g for 10 minutes, and the supernatant was then centrifuged at 3,000 x g for 15 minutes to isolate platelets and obtain platelet-poor plasma. Importantly, the time between blood sampling and platelet/plasma isolation was less than one hour. Aliquots of whole blood, platelets, and plasma were kept frozen (-20°C) until serotonin and homocysteine measurements performed within one week after congelation. Whole blood, platelet and plasma 5-HT as well as plasma homocysteine (Hcy) levels were measured by high pressure liquid chromatography coupled to fluorimetric detections .

Thrombophilia screening included measurements of antithrombin , protein C, protein S, factor V Leiden, prothrombin G20210A, methylene tetrahydrofolate reductase (MTHFR) C677T, antiphospholipid antibodies anticardiolipin IgG and IgM and anti-beta2 glycoprotein 1 IgG), dilute Russell viper venom time , Rosner index, factor VIII, von Willebrand factor (vWF) activity and antigen. Tests were performed on citrated plasma, serum or DNA as appropriate and as previously described

Eligibility criteria: Inclusion Criteria:

* adult idiopathic SSNHL

Exclusion Criteria:

* secundary hearing loss

Primary outcomes:
measure: change from Baseline of plasma serotonin at three months
timeFrame: at three months and then once a year up to five years
measure: change from Baseline of plasma homocystein at three months
timeFrame: at three months and then once a year up to five years
measure: change from Baseline serum of anticardiolipine antibody at three months
timeFrame: at three months and then once a year up to five years
Secondary outcomes:
measure: change from Baseline of hearing characteristics at three months
timeFrame: at three months and then once a year up to five years
Other outcomes:
Locations:
city: Paris
country: France
facility: HLariboisier otholaryngology clinic
Study officials:
affiliation: Hopital Lariboisière
name: jean-marie Launay, PharmD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.