- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03655509
Searching a Dysfunction of Corticotropic & Thyrotropin Axis During the Acute Phase of a Subarachnoid Hemorrhage Secondary to Spontaneous Rupture of Cerebral Aneurysm (HSA)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ACTH stimulation test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACTH stimulation test
Time Frame: 2 days
|
ACTH stimulation test compared of threshold values at 48h
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ATCH levels
Time Frame: 2 days
|
ATCH levels at 8 AM compared of threshold values at 48h
|
2 days
|
plasma cortisol
Time Frame: 2 days
|
µg per L
|
2 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Pathological Conditions, Anatomical
- Intracranial Arterial Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Rupture
- Aneurysm
- Subarachnoid Hemorrhage
- Intracranial Aneurysm
- Rupture, Spontaneous
Other Study ID Numbers
- 2012-A01386-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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