Steroid pill after brain surgery may cut bleed recurrence, but trial stopped early
NCT ID NCT01380028
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether taking oral corticosteroids (prednisone) for about two months after surgery for a chronic subdural hematoma (a slow brain bleed common in older adults) could reduce the chance of the bleed coming back. The trial planned to enroll 162 patients but was terminated early, so the results are incomplete. The approach is already used by some doctors in France, but its true benefit remains unconfirmed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- prednisone (oral corticosteroid)
- What this could lead to
- If effective, this could provide a simple, low-cost way to lower the chance of a chronic subdural hematoma coming back after surgery.
- What could go wrong
- The trial was terminated early, so results are limited. Corticosteroids have side effects like infection risk and bone thinning, and the benefit over placebo is not proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
162 people
The number who actually took part.
- Started
-
Jul 2011
- Finished
-
Sep 2014
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients of both sexes operated for chronic subdural hematoma one-sided or bilateral of firstly diagnosis, after consultation in neurosurgery for a symptomatology in touch with this hematic collection. * At the End of the surgical operation \< 72 hours * Hematoma must be hypodense or isodense. He has to present a value \< 50 on the scale of Hounsfield measured in the center of the collection on the initial intellectual scanning, this measure not in front of not to be made on a zone of new bleeding treble or on a membrane (in case of compartmentalized hematoma). The blade of the hematoma has to measure at least 3 mm in thickness on an axial cutting. Exclusion Criteria: * Age \< 18 years * Weight \> 104 kg * Histories of hematoma chronic subdural for which a medical and\\or surgical treatment were before realized * Patient Presenting: uncontrolled arterial hypertension, current Infection, Diabetes treated by drugs, Ulcer evolutionary gastroduodenal in the course of treatment and dating \< 6 months, turned out Osteoporosis symptomatic of cortisone origin, uncontrolled psychotic State by a treatment, except the sultopride, ulcerous Colitis, recent intestinal Anastomose, Renal insufficiency, hepatic Incapacity, Hypercalcemia,Hypercalciuria,calcic Lithiasis, high sensibility at drug'study, Intolerance: galactose, fructose, deficit in lactase, syndrome of malabsorption of glucose or galactose * Clinical or radiological Characteristics of hematoma suspecting an intra-cranial infection (abscess,..)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic intracranial subdural hematoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Gui de Chauliac Hospital
Montpellier, 34090, France