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Searching a Dysfunction of Corticotropic & Thyrotropin Axis During the Acute Phase of a Subarachnoid Hemorrhage Secondary to Spontaneous Rupture of Cerebral Aneurysm (HSA)

Primary Purpose

Subarachnoid Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic test ACTH stimulation
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute phase ( ≤48h) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm (Glasgow coma scale >=9)

Exclusion Criteria:

  • Pituitary failure
  • Patient with corticosteroids drugs or antithyroid drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    ACTH stimulation test

    Arm Description

    Outcomes

    Primary Outcome Measures

    ACTH stimulation test
    ACTH stimulation test compared of threshold values at 48h

    Secondary Outcome Measures

    ATCH levels
    ATCH levels at 8 AM compared of threshold values at 48h
    plasma cortisol
    µg per L

    Full Information

    First Posted
    September 13, 2016
    Last Updated
    August 30, 2018
    Sponsor
    Rennes University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03655509
    Brief Title
    Searching a Dysfunction of Corticotropic & Thyrotropin Axis During the Acute Phase of a Subarachnoid Hemorrhage Secondary to Spontaneous Rupture of Cerebral Aneurysm
    Acronym
    HSA
    Official Title
    Searching a Dysfunction of Corticotropic and Thyrotropin Axis During the Acute Phase ( ≤48h ) of a Subarachnoid Hemorrhage Secondary to Spontaneous Rupture of Cerebral Aneurysm: Impact on the Incidence of Complications and Recovery at 1 Month
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rennes University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Searching a dysfunction of corticotropic and thyrotropin axis during the acute phase ( ≤48h ) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm. Impact on the incidence of complications and recovery are evaluated at 1 month. Blood sample are made within 48 hours of the onset of bleeding with assay of total plasma cortisol, plasma ACTH at 8 am and thyroid hormones (T3, free T4 , and TSH). Dynamic test ACTH stimulation (test Synacthene) with renewal of serum cortisol to H + 1 (60min). Evaluation in the first 30 days of the incidence of rebleeding, hydrocephalus, of vasospasm, infection and epilepsy. GOS to 1 month.
    Detailed Description
    Searching a dysfunction of corticotropic and thyrotropin axis during the acute phase ( ≤48h ) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm. Impact on the incidence of complications and recovery are evaluated at 1 month. Blood sample are made within 48 hours of the onset of bleeding with assay of total plasma cortisol, plasma ACTH at 8 am and thyroid hormones (T3, free T4 , and TSH). Dynamic test ACTH stimulation (test Synacthene) with renewal of serum cortisol to H + 1 (60min). Evaluation in the first 30 days of the incidence of rebleeding, hydrocephalus, of vasospasm, infection and epilepsy. GOS to 1 month.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Subarachnoid Hemorrhage

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ACTH stimulation test
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    Dynamic test ACTH stimulation
    Primary Outcome Measure Information:
    Title
    ACTH stimulation test
    Description
    ACTH stimulation test compared of threshold values at 48h
    Time Frame
    2 days
    Secondary Outcome Measure Information:
    Title
    ATCH levels
    Description
    ATCH levels at 8 AM compared of threshold values at 48h
    Time Frame
    2 days
    Title
    plasma cortisol
    Description
    µg per L
    Time Frame
    2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Acute phase ( ≤48h) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm (Glasgow coma scale >=9) Exclusion Criteria: Pituitary failure Patient with corticosteroids drugs or antithyroid drugs

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Searching a Dysfunction of Corticotropic & Thyrotropin Axis During the Acute Phase of a Subarachnoid Hemorrhage Secondary to Spontaneous Rupture of Cerebral Aneurysm

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