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CompletedNCT00962559Updated Feb 17, 2010

Hypopituitarism After Aneurismal Subarachnoid Hemorrhage

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
26
Ages
18 Years to 85 Years
Sex
All
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Study summary

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).

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Conditions studied

  • Aneurismal Subarachnoid Hemorrhage
  • Hypopituitarism
  • Neuropsychological Deficits

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03

In context

Hypopituitarism

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 →

Lead sponsor

Universitätsmedizin Mannheim is the lead sponsor of 78 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with aSAH with a clinical grade of I-IV according to Hunt and Hess are included in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • aSAH grade I-IV Hunt und Hess
  • bleeding CCT Fisher grade 3-4
  • therapy within 48h after aSAH
  • preoperative angiography as well as control angiography
  • Glasgow Outcome Scale 4 to 5 after therapy

Exclusion criteria

Exclusion Criteria:

  • known intra-, peri- or suprasellar neoplasia
  • preexisting hypopituitarism of any degree
  • previous hormonal substitution
  • previous radiation
  • for the neuropsychological examination: difficulties with German language
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
26 participants (estimated)
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What researchers measure

Primary outcomes

  1. hypopituitarism of any degree

    Time frame: one year

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Study locations

1 site
  • Universitätsmedizin Mannheim
    Mannheim, BW 68169, Germany
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References and documents

Publications

  • Suarez JI, Tarr RW, Selman WR. Aneurysmal subarachnoid hemorrhage. N Engl J Med. 2006 Jan 26;354(4):387-96. doi: 10.1056/NEJMra052732. No abstract available. PubMed 16436770 ↗
  • Ogden JA, Mee EW, Henning M. A prospective study of impairment of cognition and memory and recovery after subarachnoid hemorrhage. Neurosurgery. 1993 Oct;33(4):572-86; discussion 586-7. doi: 10.1227/00006123-199310000-00004. PubMed 8232796 ↗
  • Anderson SW, Todd MM, Hindman BJ, Clarke WR, Torner JC, Tranel D, Yoo B, Weeks J, Manzel KW, Samra S. Effects of intraoperative hypothermia on neuropsychological outcomes after intracranial aneurysm surgery. Ann Neurol. 2006 Nov;60(5):518-527. doi: 10.1002/ana.21018. PubMed 17120252 ↗
  • Schneider HJ, Kreitschmann-Andermahr I, Ghigo E, Stalla GK, Agha A. Hypothalamopituitary dysfunction following traumatic brain injury and aneurysmal subarachnoid hemorrhage: a systematic review. JAMA. 2007 Sep 26;298(12):1429-38. doi: 10.1001/jama.298.12.1429. PubMed 17895459 ↗
  • Brabant G, Krogh Rasmussen A, Biller BM, Buchfelder M, Feldt-Rasmussen U, Forssmann K, Jonsson B, Koltowska-Haggstrom M, Maiter D, Saller B, Toogood A. Clinical implications of residual growth hormone (GH) response to provocative testing in adults with severe GH deficiency. J Clin Endocrinol Metab. 2007 Jul;92(7):2604-9. doi: 10.1210/jc.2007-0153. Epub 2007 May 8. PubMed 17488801 ↗
  • Lindholm J, Kehlet H. Re-evaluation of the clinical value of the 30 min ACTH test in assessing the hypothalamic-pituitary-adrenocortical function. Clin Endocrinol (Oxf). 1987 Jan;26(1):53-9. doi: 10.1111/j.1365-2265.1987.tb03638.x. PubMed 3026692 ↗
  • Growth Hormone Research Society. Consensus guidelines for the diagnosis and treatment of growth hormone (GH) deficiency in childhood and adolescence: summary statement of the GH Research Society. GH Research Society. J Clin Endocrinol Metab. 2000 Nov;85(11):3990-3. doi: 10.1210/jcem.85.11.6984. No abstract available. PubMed 11095419 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

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.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2009
First posted
Aug 20, 2009
Start
Feb 2008
Primary completionActual
Feb 2010
CompletionActual
Feb 2010
Last update
Feb 17, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00962559
Lead sponsor
Universitätsmedizin Mannheim
First posted
Aug 20, 2009
Start date
Feb 2008
Primary completion
Feb 2010
Completion
Feb 2010
Last update
Feb 17, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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