Chronic Subdural HematomasPhase 3SUCRENCT02650609
Treatment of Chronic Subdural Hematoma by Corticosteroids
A Phase 3 study testing Methylprednisolone in people with Chronic Subdural Hematomas, run by Rennes University Hospital at 17 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematomas
- What is being tested?
- Methylprednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 17 sitesFrance
- Study dates
- 24 Jun 2016to 20 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CHU Amiens
Amiens
CHU Angers
Angers
CHU Besançon
Besançon
CHU Bordeaux Neurochirurgie A
Bordeaux
CHU Bordeaux Neurochirurgie B
Bordeaux
CHU Brest
Brest
CHU Caen
Caen
CHU Lille
Lille
HC Lyon
Lyon
AP-HM - Hôpital La Timone
Marseille
CHU Nancy
Nancy
CHU Nantes
Nantes
CHU Poitiers
Poitiers
CHU Rouen
Rouen
CHU Saint Etienne
Saint-Etienne
CHU Strasbourg
Strasbourg
CHU Tours
Tours
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Subdural Hematomas
- Being tested
- Methylprednisolone, Placebo
- Keywords
- chronic subdural hematomas, surgical treatment, corticosteroids
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | Methylprednisolone will be supplied as powder and stored in capsules containing 16 mg with lactose as excipient.
Capsules will be administered orally in the morning, during breakfast with a glass of water.
Dose is adapted according to the weight of the patient (1mg/kg):
* <60 kg: 3 pills of 16 mg/day
* 60-80kg: 4 pills of 16 mg/day
* >80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days. Receives: Drug: Methylprednisolone |
| Placebo | Placebo comparator | Placebo capsules will only contain lactose. Capsules will be administered orally in the morning, during breakfast with a glass of water.
Dose is adapted according to the weight of the patient (1mg/kg):
* <60 kg: 3 pills of 16 mg/day
* 60-80kg: 4 pills of 16 mg/day
* >80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay of occurrence of surgical treatment of the Chronic subdural hematomas
Measured: 1 month
Secondary outcomes (12)
Quality of life score
Short Form Health Survey 12 scale
Measured: 1, 3 and 6 months
Time to surgical treatment
Measured: during the first 6 months
Rate of surgical treatment of the Chronic subdural hematomas
Measured: 1, 3 and 6 months
Functional scales : daily living
Instrumental Activities of Daily Living scale
Measured: 1, 3 and 6 months
Functional scales : cognitive
Mini-Mental State Examination scale
Measured: 1, 3 and 6 months
Functional scales : modified Rankin Scale
modified Rankin Scale
Measured: 1, 3 and 6 months
Plasma sodium
Measured: day 0, 7, 14, and 21 and 1 month
Potassium
Measured: day 0, 7, 14, and 21 and 1 month
Fasting glucose
Measured: day 0, 7, 14, and 21 and 1 month
Occurrence of adverse events potentially related to methylprednisolone
Measured: during the first 6 months
Survival
Measured: 6 months
Radiological improvement
Radiological improvement defined by reduction of maximal thickness of hematoma and reduction of midline shift evaluated
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start24 Jun 2016
- Primary completion20 Mar 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomasStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier XM MORANDI, MD, PhD, Principal investigator, Rennes University HospitalPierre-Louis PH HENAUX, MD, Principal investigator, Rennes University HospitalPierre-Jean PL LE RESTE, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650609
- Sponsor's protocol ID
- 2015-000927-96
- Other IDs
- 2015
- Acronym
- SUCRE
- Status last verified
- Jun 2020
- First submitted
- 4 Jan 2016
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fougerou-Leurent C, Forteau L, Perrot-Loyer M, Renault A, Brion M, Mouchel C, Rousseau C, Marion E, Cochennec S, Ganivet A, Gervais ML, Fin L, Laviolle B. Evaluating the Environmental Impact of Clinical Research: A Full Life Cycle Analysis of a French Academic Randomised Clinical Trial. Fundam Clin Pharmacol. 2026 May;40(3):e70086. doi: 10.1111/fcp.70086.
PubMed 41999149Henaux PL, Le Reste PJ, Laviolle B, Morandi X. Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):252. doi: 10.1186/s13063-017-1990-8.
PubMed 28583162
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Subdural Hematoma by Corticosteroids
- ClinicalTrials.gov ID
- NCT02650609
- Acronym / sponsor ID
- SUCRE / 2015-000927-96
- Conditions
- Chronic Subdural Hematomas
- Keywords
- chronic subdural hematomas, surgical treatment, corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2016 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: MethylprednisoloneMethylprednisolone will be supplied as powder and stored in capsules containing 16 mg with lactose as excipient. Capsules will be administered orally in the morning, during breakfast with a glass of water. Dose is adapted according to the weight of the patient (1mg/kg): * <60 kg: 3 pills of 16 mg/day * 60-80kg: 4 pills of 16 mg/day * >80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules will only contain lactose. Capsules will be administered orally in the morning, during breakfast with a glass of water. Dose is adapted according to the weight of the patient (1mg/kg): * <60 kg: 3 pills of 16 mg/day * 60-80kg: 4 pills of 16 mg/day * >80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone | Drug | Methylprednisolone |
| Placebo | Drug | Placebo |
Primary outcome
Delay of occurrence of surgical treatment of the Chronic subdural hematomas
Time frame: 1 month
12 secondary outcomes
Quality of life score
Time frame: 1, 3 and 6 months
Time to surgical treatment
Time frame: during the first 6 months
Rate of surgical treatment of the Chronic subdural hematomas
Time frame: 1, 3 and 6 months
Functional scales : daily living
Time frame: 1, 3 and 6 months
Functional scales : cognitive
Time frame: 1, 3 and 6 months
Functional scales : modified Rankin Scale
Time frame: 1, 3 and 6 months
Plasma sodium
Time frame: day 0, 7, 14, and 21 and 1 month
Potassium
Time frame: day 0, 7, 14, and 21 and 1 month
Fasting glucose
Time frame: day 0, 7, 14, and 21 and 1 month
Occurrence of adverse events potentially related to methylprednisolone
Time frame: during the first 6 months
Survival
Time frame: 6 months
Radiological improvement
Time frame: 1, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 41999149Fougerou-Leurent C, Forteau L, Perrot-Loyer M, Renault A, Brion M, Mouchel C, Rousseau C, Marion E, Cochennec S, Ganivet A, Gervais ML, Fin L, Laviolle B. Evaluating the Environmental Impact of Clinical Research: A Full Life Cycle Analysis of a French Academic Randomised Clinical Trial. Fundam Clin Pharmacol. 2026 May;40(3):e70086. doi: 10.1111/fcp.70086.
- Derived from this study: PubMed 28583162Henaux PL, Le Reste PJ, Laviolle B, Morandi X. Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):252. doi: 10.1186/s13063-017-1990-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier XM MORANDI, MD, PhD principal investigator
Rennes University Hospital
Pierre-Louis PH HENAUX, MD principal investigator
Rennes University Hospital
Pierre-Jean PL LE RESTE, MD principal investigator
Rennes University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone in people with Chronic Subdural Hematomas, run by Rennes University Hospital at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay of occurrence of surgical treatment of the Chronic subdural hematomas (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02650609, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.