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

NCT ID: NCT03655509

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subarachnoid Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACTH stimulation test

Group Type OTHER

Dynamic test ACTH stimulation

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dynamic test ACTH stimulation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-A01386-37

Identifier Type: -

Identifier Source: org_study_id