Searching a Dysfunction of Corticotropic & Thyrotropin Axis During the Acute Phase of a Subarachnoid Hemorrhage Secondary to Spontaneous Rupture of Cerebral Aneurysm
HSA
1 other identifier
interventional
26
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 31, 2018
February 1, 2018
2.7 years
September 13, 2016
August 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
ACTH stimulation test
ACTH stimulation test compared of threshold values at 48h
2 days
Secondary Outcomes (2)
ATCH levels
2 days
plasma cortisol
2 days
Study Arms (1)
ACTH stimulation test
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Acute phase ( ≤48h) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm (Glasgow coma scale \>=9)
You may not qualify if:
- Pituitary failure
- Patient with corticosteroids drugs or antithyroid drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2016
First Posted
August 31, 2018
Study Start
June 1, 2013
Primary Completion
February 1, 2016
Study Completion
December 1, 2018
Last Updated
August 31, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share