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

Subarachnoid Hemorrhage Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03655509
• Other study ID #: 2012-A01386-37
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Intracranial Aneurysm
• Rupture
• Rupture, Spontaneous
• Subarachnoid Hemorrhage

Intervention

Procedure:
• Dynamic test ACTH stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACTH stimulation test	ACTH stimulation test compared of threshold values at 48h	2 days
Secondary	ATCH levels	ATCH levels at 8 AM compared of threshold values at 48h	2 days
Secondary	plasma cortisol	µg per L	2 days