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

Not Applicable

• Conditions: Subarachnoid Hemorrhage
• Interventions: Procedure: Dynamic test ACTH stimulation

• Registration Number: NCT03655509
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2016-02
• Study First Submitted: 2016-09-13
• Status Verified: 2018-02
• Study First Submitted QC: 2018-08-30
• Last Update Submitted: 2018-08-30
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACTH stimulation test	Dynamic test ACTH stimulation	-

Primary Outcome Measures

Name	Time	Method
ACTH stimulation test	2 days	ACTH stimulation test compared of threshold values at 48h

Secondary Outcome Measures

Name	Time	Method
plasma cortisol	2 days	µg per L
ATCH levels	2 days	ATCH levels at 8 AM compared of threshold values at 48h