An observational study in Aneurismal Subarachnoid Hemorrhage, Hypopituitarism and Neuropsychological Deficits, sponsored by Universitätsmedizin Mannheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-02-17.
Sponsored by Universitätsmedizin Mannheim · Observational
Introduction:
Almost 50% of patients die after aneurismal subarachnoid hemorrhage (aSAH). 30% of the survivors suffer from neurological handicap and need permanent care (Suarez et al.). Even when neurological outcome is good, neuropsychological deficits are frequently observed (Ogden et al., Anderson et al.) The incidence rate of aSAH is almost 8 of 100.000 per year. Due to similar clinical symptoms to patients with hypopituitarism, several studies have analyzed the incidence of hypopituitarism after aSAH. Dysfunction of the anterior pituitary gland was found in up to 47% (Schneider et al.). GH deficiency was demonstrated in almost every fourth patient and an association with poor recovery was postulated. In Germany, the investigators would therefore expect as many as 1200 patients with incident GH deficiency. The KIMS-study is an observational GH-treatment study in adult onset growth hormone deficiency. Within the epidemiological data of KIMS, aSAH is not known as a relevant contributing cause (Brabant et al.). This resembles much of the investigators clinical experience that there is no huge prevalence of hypopituitarism after aSAH.
Objective: Evaluation of the frequency of hypopituitarism and neuropsychological dysfunction of any degree in patients with aSAH in a prospective approach.
Methods:
The investigators conduct a prospective study for the evaluation of endocrine deficiency with aSAH. The investigators study patients 3, 6 and 12 month after aneurismal bleeding. Patients diagnosed with aSAH with a clinical grade of I-IV according to Hunt and Hess are included in the study. The investigators perform basal testing for the pituitary by measuring: TSH, LH, FSH, IGF-1, GH, prolactin and ACTH. For evaluation of the adrenal function the investigators perform an ACTH-stimulation test (Lindholm et al.). Subjects with evidence for adrenal or GH insufficiency are further analyzed by insulin-induced hypoglycemia testing (GH Research Society). In the neuropsychological examination, the investigators screen for verbal comprehension (Token Test, short form) and visual neglect (line bisection). Verbal and visual short term memory (digit and spatial span), visuospatial construction and figural memory (Rey Osterrieth Complex Figure Test), psychomotor speed, attention and concentration (Trail Making Test Part A and B, d2) as well as mental flexibility (word fluency) are assessed. Patients additionally fill out a questionnaire measuring actual depressive symptoms and anxiety (Hospital Anxiety and Depression Scale).
47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.
This study's planned enrollment of 26 is below the median of 137 across 17 observational studies indexed under Hypopituitarism.
Browse Hypopituitarism studies →Universitätsmedizin Mannheim is the lead sponsor of 78 studies on the registry; 2 are open to participants now.
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Patients diagnosed with aSAH with a clinical grade of I-IV according to Hunt and Hess are included in the study.
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Exclusion Criteria:
hypopituitarism of any degree
Time frame: one year
The record gives a start of Feb 2008, a primary completion of Feb 2010 and a completion of Feb 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Universitätsmedizin Mannheim