NCT02915380|Unknown
Pituitary Dysfunction After Aneurysmal Subarachnoid Hemorrhage
TIRASH
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TIRASH
Sponsor study identifier
observational
50
0 countries
N/A
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Recently, the occurrence and potential impact of pituitary dysfunction after aSAH has gained increasing interest. Several studies have demonstrated pituitary dysfunction after SAH suggesting that pituitary dysfunction may be a contributing factor for residual symptoms after SAH. This is an observational multicentric study aimed to test the prevalence of thyroid abnormalities, other neuroendocrinological dysfunction and their influence on outcome of patients affected by aSAH.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 6, 2016
Actual (reported)September 27, 2016
Actual (reported)January 2017
Date type not reportedThis date has not been verified as actual or estimated.
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of thyroid disfunction
Thyroid-stimulating hormone (TSH), free thyroxin (fT4), free triiodothyronine (fT3).
At 2 weeks after aSAH
Incidence of thyroid disfunction
Thyroid-stimulating hormone (TSH), free thyroxin (fT4), free triiodothyronine (fT3).
3 months after aSAH
Incidence of thyroid disfunction
Thyroid-stimulating hormone (TSH), free thyroxin (fT4), free triiodothyronine (fT3).
6 months after aSAH
Incidence of thyroid disfunction
Thyroid-stimulating hormone (TSH), free thyroxin (fT4), free triiodothyronine (fT3).
12 months after aSAH
Incidence of pituitary- sexual hormones disfunction
At 2 weeks, and at follow up at 3, 6 and 12 months.
Survival
At 2 weeks, and at follow up at 3, 6 and 12 months
Incidence of pituitary-adrenal axis disfunction
At 2 weeks, and at follow up at 3, 6 and 12 months.
Incidence of growth hormone insufficiency
At 2 weeks, and at follow up at 3, 6 and 12 months
Incidence of language disorders
At 2 weeks, and at follow up at 3, 6 and 12 months
The basal thyroid hormone and test to perform will be: TSH, fT4, fT3. When available, the following hormones will be tested: FSH, LH, estradiol (in women), testosterone (in men), sex hormone-binding globulin (SHBG), ACTH, cortisol, prolactin, Na, K; serum levels of GH and IGF-1; and serum and urine osmolality. Adrenal function will be evaluated through ACTH-stimulation testing . Adrenal or GH insufficiency will be evaluated by insulin tolerance testing (ITT)
Patients' outcome will be assessed as modified Rankin Scale (mRS) at discharge from the hospital, at 3, 6 and 12 months.
Patients admitted for aneurysmal subarachnoid haemorrhage
Chiara Robba, MD
Cambridge University Hospitals NHS Foundation Trust
First Submitted
September 6, 2016
First Posted
September 27, 2016
Study Start
January 2017
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2018
Neuropsychological examination will be conducted focusing on verbal comprehension (Token Test) and visual neglect. Verbal and visual short term and working memory visuospatial construction and figural memory will be performed through Rey Osterrieth Complex figure test, and psychomotor speed attention and concentration through Trail Making Test.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 27, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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