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
About this trial
This is an interventional diagnostic trial for Subarachnoid Hemorrhage
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
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
NCT ID
NCT03655509
First Posted
September 13, 2016
Last Updated
August 30, 2018
Sponsor
Rennes University Hospital
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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