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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
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microvascular markers | Diagnostic Test | follow up of microvascular biomarkers during patient follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change from Baseline of hearing characteristics at three months | audiogram | at three months and then once a year up to five years |
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Inclusion Criteria:
Exclusion Criteria:
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unrelated adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic of our university hospital
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| Name | Affiliation | Role |
|---|---|---|
| jean-marie Launay, PharmD, PhD | Hopital Lariboisière | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HLariboisier otholaryngology clinic | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16461587 | Background | 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. | |
| 21859903 | Result | 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. |
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it will be decided at completion of patient recruitement
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| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| D019851 | Thrombophilia |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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venous peripheral blood
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |