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Pituitary Function and Spontaneous Intracranial Hypotension

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ClinicalTrials.gov Identifier: NCT02603549
Recruitment Status : Suspended (Study protocol needs to be amended. Recruitment is halted until amendment is completed and approved by IRB.)
First Posted : November 13, 2015
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Vivien Bonert, MD, Cedars-Sinai Medical Center

Brief Summary:
Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for spontaneous intracranial hypotension, leading to positional headache patterns. Typical magnetic resonance imaging findings include subdural fluid collections, enhancement of pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the investigators would like to like to assess the clinical manifestations and neuroimaging abnormalities of SIH patients with regard to the pituitary gland. Specifically, the investigators are looking to analyze the compression of the pituitary stalk and conduct a systemic evaluation of pituitary function in SIH patients.

Condition or disease Intervention/treatment
Hyperprolactinemia Spontaneous Intracranial Hypotension Other: Pituitary panel will be drawn pre-op and post-op for all patients.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension
Study Start Date : July 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Group/Cohort Intervention/treatment
Surgery or Blood Patch Other: Pituitary panel will be drawn pre-op and post-op for all patients.



Primary Outcome Measures :
  1. Comparing the levels of prolactin pre and post treatment [ Time Frame: 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Spontaneous intracranial hypotension (SIH)
Criteria

Inclusion Criteria:

  • Male or female patients
  • Age 18 years and older
  • Diagnosis of SIH:
  • LP
  • Brain MRI (SEEPS)

Exclusion Criteria:

  • Pregnant and post-partum females
  • Nursing mothers
  • Patients with potential hyperprolactinemia due to:
  • Hypothyroidism,
  • Chronic renal disorder
  • Liver disease (including cirrhosis)
  • Primary or secondary amenorrhea
  • Polycystic Ovary Syndrome
  • Seizure disorder
  • Illicit drug use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603549


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Vivien Bonert, MD Cedars-Sinai Medical Center

Publications:
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Responsible Party: Vivien Bonert, MD, Clinical Director, Pituitary Center, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02603549     History of Changes
Other Study ID Numbers: Pro39357
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Hyperprolactinemia
Intracranial Hypotension
Hypotension
Vascular Diseases
Cardiovascular Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases