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OpenTrials
Completed

NCT Number: NCT03919474

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult idiopathic SSNHL

Exclusion criteria

  • secundary hearing loss

Treatment and study plan

microvascular markers

Diagnostic Test

follow up of microvascular biomarkers during patient follow up

Primary outcomes

  1. change from Baseline of plasma serotonin at three months

    Time frame: at three months and then once a year up to five years

    plasma serotonin level (HPLC, frequent value <15nM)

  2. change from Baseline of plasma homocystein at three months

    Time frame: at three months and then once a year up to five years

    plasma homocystein (HPLC, fequent value <15 µM)

  3. change from Baseline serum of anticardiolipine antibody at three months

    Time frame: at three months and then once a year up to five years

    serum anticardiolipin antiboy (ELISA, frequent value <10units)

Secondary outcomes

  1. change from Baseline of hearing characteristics at three months

    Time frame: at three months and then once a year up to five years

    audiogram

Sponsors and collaborators

Lead sponsor

Hopital Lariboisière

Other

Registry information

Official study title

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

Acronym: SSNHL

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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