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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
Plain-language guide to NCT03655509: not phased interventional trial of ACTH (Corticotropin), 26 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03655509
- Phase
- not phased
- Status
- completed
- Start
- 2015-08-22
- Completion (planned or actual)
- 2016-12-31
- Participants
- 26 (actual)
- Design
- na, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Subarachnoid Hemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around ACTH (Corticotropin).
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).
It had 1 arm (groups): ACTH stimulation test (other).
The registry classes the interventions as procedure.
Who Took Part
26 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Acute phase ( ≤48h) of a subarachnoid hemorrhage secondary to spontaneous rupture of cerebral aneurysm (Glasgow coma scale \>=9).
The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: pituitary failure; patient with corticosteroids drugs or antithyroid drugs.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the ACTH (Corticotropin) study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2015-08-22 with completion listed for 2016-12-31.
It ran at 1 site in France.
Its stated primary purpose is diagnostic.
What Was Measured
Researchers chose this as the main measure: ACTH stimulation test (time frame: 2 days).
It also tracked 2 secondary outcomes, for example ATCH levels and plasma cortisol.
What This Means in Plain Language
Put simply, this is a not phased trial of ACTH (Corticotropin) in 26 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the ACTH (Corticotropin) compound page, all human trials.
Our Notes on the Compound
ACTH (Corticotropin): The 39-amino-acid pituitary hormone that drives cortisol production; given as repository corticotropin (Acthar Gel).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.