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

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ClinicalTrials.gov Identifier: NCT03655509
Recruitment Status : Active, not recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Procedure: Dynamic test ACTH stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : June 2013
Actual Primary Completion Date : February 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ACTH stimulation test Procedure: Dynamic test ACTH stimulation



Primary Outcome Measures :
  1. ACTH stimulation test [ Time Frame: 2 days ]
    ACTH stimulation test compared of threshold values at 48h


Secondary Outcome Measures :
  1. ATCH levels [ Time Frame: 2 days ]
    ATCH levels at 8 AM compared of threshold values at 48h

  2. plasma cortisol [ Time Frame: 2 days ]
    µg per L



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03655509     History of Changes
Other Study ID Numbers: 2012-A01386-37
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Brain Diseases
Hemorrhage
Subarachnoid Hemorrhage
Rupture
Rupture, Spontaneous
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries
Intracranial Arterial Diseases
Pathological Conditions, Anatomical