NCT03655509

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

September 13, 2016

Last Update Submit

June 10, 2026

Conditions

Subarachnoid Hemorrhage

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

OTHER
Procedure: Dynamic test ACTH stimulation

Interventions

Dynamic test ACTH stimulationPROCEDURE
ACTH stimulation test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Rennes University Hospital

Rennes, France

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

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

August 22, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)