Pituitary Dysfunction After Aneurysmal Subarachnoid Hemorrhage

NCT02915380 | Unknown

• 1 other identifier: TIRASH-1.0
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thyroid Disfunction; Subarachnoid Haemorrhage From Cerebral Aneurism Rupture; Pituitary Disfunction

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (7)

• 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

Interventions

Evaluation of pituitary endocrine function BIOLOGICAL

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)

Evaluation of clinical outcome BEHAVIORAL

Patients' outcome will be assessed as modified Rankin Scale (mRS) at discharge from the hospital, at 3, 6 and 12 months.

Evaluation of neuropsychological function BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for aneurysmal subarachnoid haemorrhage

You may qualify if:

• patients with acute aneurysmal SAH aged between 18 and 70 years of age who could be subjected to endocrine evaluation within 10 days of ictus and at follow-up.

You may not qualify if:

• be major depression, psychiatric premorbidity, pituitary adenoma or perisellar lesion,preexisting hypopituitarism of any degree, previous hormonal substitution, patients in moribund state, pregnancy, glucocorticoid medication on admission to hospital or during treatment, prior pituitary insufficiency, and unsalvageable aSAH.

Sponsors & Collaborators

• Dr. Rita Bertuetti: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Officials

• Chiara Robba, MD

  Cambridge University Hospitals NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Chiara Robba, MD

CONTACT

kiarobba@gmail.com

Rita Bertuetti, MD

CONTACT

rita_zoso@yahoo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 27, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 27, 2016

Record last verified: 2016-09