Blood Markers in Adult Patients With Sudden Sensorineural Hearing Loss (SSNHL)

Completed

• Conditions: Idiopathic SSNHL; Age Over 18

• Registration Number: NCT03919474
• Lead Sponsor: Hopital Lariboisière

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

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-18
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

• adult idiopathic SSNHL

Exclusion Criteria

• secundary hearing loss

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change from Baseline of plasma serotonin at three months	at three months and then once a year up to five years	plasma serotonin level (HPLC, frequent value \<15nM)
change from Baseline of plasma homocystein at three months	at three months and then once a year up to five years	plasma homocystein (HPLC, fequent value \<15 µM)
change from Baseline serum of anticardiolipine antibody at three months	at three months and then once a year up to five years	serum anticardiolipin antiboy (ELISA, frequent value \<10units)

Secondary Outcome Measures

Name	Time	Method
change from Baseline of hearing characteristics at three months	at three months and then once a year up to five years	audiogram

Trial Locations

Locations (1)

HLariboisier otholaryngology clinic; 🇫🇷 Paris, France