Skip to main content
OpenTrials
Completed

NCT Number: NCT02650609

Treatment of Chronic Subdural Hematoma by Corticosteroids

Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural hematoma involves numerous inflammatory processes which could be inhibited by steroids.

Completed

Looking for future studies?

Notify Me

Key information

About this study

The primary objective is to evaluate the efficacy of corticosteroids treatment in patients with Chronic subdural hematomas without clinical or radiological signs of severity.

Secondary objectives are to assess the effect of methylprednisolone on:

  • quality of life evolution,
  • morbidity and mortality,
  • radiological evolution of the lesions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years old,
  • With chronic or subacute, uni or bilateral subdural hematoma,
  • Confirmed by cerebral scan without contrast enhancement,
  • Without clinical and radiological signs of severity,
  • Written informed consent from patients or their next of kin according to the patients cognitive status.

Exclusion criteria

  • Diabetics patients,
  • Contraindication for methylprednisolone,
  • Previous surgery for chronic subdural hematoma during the past 6 months,
  • Pre-existing severe dementia related to other etiology than the Chronic subdural hematomas,
  • Existing neurological pathology that can be associated with dementia,
  • Patients treated with corticosteroids,
  • Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor),
  • Participating in other concomitant research.

Treatment and study plan

methylprednisolone

Drug

Placebo

Drug

Primary outcomes

  1. Delay of occurrence of surgical treatment of the Chronic subdural hematomas

    Time frame: 1 month

Secondary outcomes

  1. Quality of life score

    Time frame: 1, 3 and 6 months

    Short Form Health Survey 12 scale

  2. Time to surgical treatment

    Time frame: during the first 6 months

  3. Rate of surgical treatment of the Chronic subdural hematomas

    Time frame: 1, 3 and 6 months

  4. Functional scales : daily living

    Time frame: 1, 3 and 6 months

    Instrumental Activities of Daily Living scale

  5. Functional scales : cognitive

    Time frame: 1, 3 and 6 months

    Mini-Mental State Examination scale

  6. Functional scales : modified Rankin Scale

    Time frame: 1, 3 and 6 months

    modified Rankin Scale

  7. Plasma sodium

    Time frame: day 0, 7, 14, and 21 and 1 month

  8. Potassium

    Time frame: day 0, 7, 14, and 21 and 1 month

  9. Fasting glucose

    Time frame: day 0, 7, 14, and 21 and 1 month

  10. Occurrence of adverse events potentially related to methylprednisolone

    Time frame: during the first 6 months

  11. Survival

    Time frame: 6 months

  12. Radiological improvement

    Time frame: 1, 3 and 6 months

    Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: SUCRE

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 8, 2016
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.