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出境医 / 临床实验 / Blood Markers in Adult Patients With Sudden Sensorineural Hearing Loss (SSNHL) (SSNHL)

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

Study Description
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

Condition or disease Intervention/treatment
Idiopathic SSNHL Age Over 18 Diagnostic Test: microvascular markers

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 Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 394 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Markers of Microvascular Lesion in Adult Patients With Acquired Sudden Cochelo-vestibular Deficiency
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
venous peripheral blood

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date April 2, 2019
First Posted Date April 18, 2019
Last Update Posted Date February 10, 2021
Actual Study Start Date January 2016
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2019)
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 15, 2019) 		change from Baseline of hearing characteristics at three months [ Time Frame: at three months and then once a year up to five years ]
audiogram
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
venous peripheral blood
Sampling Method Non-Probability Sample
Study Population unrelated adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic of our university hospital
Condition
  • Idiopathic SSNHL
  • Age Over 18
Intervention Diagnostic Test: microvascular markers
follow up of microvascular biomarkers during patient follow up
Study Groups/Cohorts Not Provided
Publications *
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 8, 2021) 		394
Original Estimated Enrollment
 (submitted: April 15, 2019) 		300
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • adult idiopathic SSNHL

Exclusion Criteria:

  • secundary hearing loss
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03919474
Other Study ID Numbers HLariboisiere-ORL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: it will be decided at completion of patient recruitement
Responsible Party Ludovic Drouet MD, PhD, Hopital Lariboisière
Study Sponsor Hopital Lariboisière
Collaborators Not Provided
Investigators
Study Director: jean-marie Launay, PharmD, PhD Hopital Lariboisière
PRS Account Hopital Lariboisière
Verification Date February 2021

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