Chronic Subdural HematomaPhase 2NCT02192320
The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
A Phase 2 study testing Atorvastatin and Atorvastatin and Dexamethasone in people with Chronic Subdural Hematoma, run by Oriental Neurosurgery Evidence-Based-Study Team at 2 sites in China.
Trial summary
To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Atorvastatin and Atorvastatin and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2014to Sep 2015
- Phase
- Phase 2
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and<90years old, both gender;
- Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders;
- CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
- The midline shift to less than 1 cm;
- Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted;
- Patients have never undergo surgery on the hematoma;
- Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.
Who cannot join
- Allergic to the statin and dexamethasone or its ingredients;
- Hematoma caused by tumors, blood and other known comorbidities;
- Abnormal liver function;
- Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study;
- Patients have been on oral Statin treatment in the past four weeks;
- Patients have been on oral Steroids treatment for a long time;
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- Diagnosed Diabetes patients with poorly controlled blood glucose
- Participate in clinical trials in the past four weeks;
- Pregnant or breastfeeding;
- Failure of completing the trial by poor compliance;
- For any reason, the researchers believe that the case is not suitable for inclusion.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders
Read the detailed description
Study design: Two-arm,Evaluator-blinded study
Subjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted）
Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in Atorvastatin-treated group.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Atorvastatin, Atorvastatin and Dexamethasone
- Keywords
- Atorvastatin, Atorvastatin and Dexamethasone, Chronic Subdural Hematoma, conservative treatment
- 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.
AtorvastatinDrug
20 mg (every evening orally) for 5 weeks
Atorvastatin and DexamethasoneDrug
Atorvastatin: 20 mg (every evening orally) for 5 weeks;
Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin and Dexamethasone | Experimental | Atorvastatin: 20 mg (every evening orally) for 5 weeks;
Dexamethasone: 0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week) Receives: Drug: Atorvastatin and Dexamethasone |
| Atorvastatin | Active comparator | Atorvastatin: 20 mg (every evening orally) for 5 weeks Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of hematoma volume
After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.
Measured: 2,5,12 weeks during treatment
Secondary outcomes (5)
Outcome score (GOSE) in subjects
Measured: 2,5,12 weeks during treatment
Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis
Measured: 2,5,12 weeks during treatment
Changes of neurological symptoms and signs
Measured: 2,5,12 weeks during treatment
Recurrence and prognosis of patient failure in those conservative treatment
Measured: 2,5,12 weeks during treatment
Outcome score (ADL-BI Scale) in subjects
Measured: 2,5,12 weeks during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oriental Neurosurgery Evidence-Based-Study Team
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192320
- Sponsor's protocol ID
- CSDH2014
- Status last verified
- Mar 2015
- First submitted
- 11 Jul 2014
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
- ClinicalTrials.gov ID
- NCT02192320
- Acronym / sponsor ID
- CSDH2014
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Atorvastatin, Atorvastatin and Dexamethasone, Chronic Subdural Hematoma, conservative treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oriental Neurosurgery Evidence-Based-Study TeamUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 16 Jul 2014 (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.
To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders
Detailed description
Study design: Two-arm,Evaluator-blinded study
Subjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted）
Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in Atorvastatin-treated group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin and Dexamethasone | Experimental | Drug: Atorvastatin and DexamethasoneAtorvastatin: 20 mg (every evening orally) for 5 weeks; Dexamethasone: 0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week) |
| Atorvastatin | Active comparator | Drug: AtorvastatinAtorvastatin: 20 mg (every evening orally) for 5 weeks |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 and<90years old, both gender;
- Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders;
- CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
- The midline shift to less than 1 cm;
- Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted;
Key exclusion criteria (11 listed)
- Allergic to the statin and dexamethasone or its ingredients;
- Hematoma caused by tumors, blood and other known comorbidities;
- Abnormal liver function;
- Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study;
- Patients have been on oral Statin treatment in the past four weeks;
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 |
|---|---|---|
| Atorvastatin20 mg (every evening orally) for 5 weeks | Drug | Atorvastatin |
| Atorvastatin and DexamethasoneAtorvastatin: 20 mg (every evening orally) for 5 weeks; Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week) | Drug | Atorvastatin and Dexamethasone |
Primary outcome
Changes of hematoma volume
Time frame: 2,5,12 weeks during treatment
After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.
5 secondary outcomes
Outcome score (GOSE) in subjects
Time frame: 2,5,12 weeks during treatment
Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis
Time frame: 2,5,12 weeks during treatment
Changes of neurological symptoms and signs
Time frame: 2,5,12 weeks during treatment
Recurrence and prognosis of patient failure in those conservative treatment
Time frame: 2,5,12 weeks during treatment
Outcome score (ADL-BI Scale) in subjects
Time frame: 2,5,12 weeks during treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin and Atorvastatin and Dexamethasone in people with Chronic Subdural Hematoma, run by Oriental Neurosurgery Evidence-Based-Study Team at 2 sites in China.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongcai Jiang, PhD (86-22-60814348, jianghope@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of hematoma volume (time frame: 2,5,12 weeks during treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2015.