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

Age Over 18 Clinical Trial

— SSNHL  

Official title:

Markers of Microvascular Lesion in Adult Patients With Acquired Sudden Cochelo-vestibular Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919474
• Other study ID #: HLariboisiere-ORL
• Status: Completed
• Start date: January 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2021
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult idiopathic SSNHL

Exclusion Criteria:

• secundary hearing loss

Related Conditions & MeSH terms

• Age Over 18
• Hearing Loss
• Idiopathic SSNHL

Intervention

Diagnostic Test:
• microvascular markers
follow up of microvascular biomarkers during patient follow up

Locations

Country	Name	City	State
France	HLariboisier otholaryngology clinic	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Review. — View Citation

Callebert J, Esteve JM, Hervé 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. Epub 2006 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	change from Baseline of hearing characteristics at three months	audiogram	at three months and then once a year up to five years