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A multicenter, randomized, double-blind, placebo-controlled, clinical study of dexamethasone combined with atorvastatin in the treatment of spontaneous intracerebral parenchymal hematoma

A multicenter, randomized, double-blind, placebo-controlled, clinical study of dexamethasone combined with atorvastatin in the treatment of spontaneous intracerebral parenchymal hematoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TIC-17013553
Enrollment
Unknown
Registered
2017-11-27
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hemorrhage

Interventions

Placebo:Placebo
Atorvastatin:Atorvastatin 20mg, QN
Dexamethasone:Dexamethasone 0.75mg, tid
Atorvastatin&Dexamethasone:Atorvastatin 20mg, QN & Dexamethasone 0.75mg, tid

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years male and female; 2. GCS> 8, head CT or MRI clearly shows spontaneous intracerebral hematoma (hematoma volume less than 30ml); 3. Hematoma occurs less than 72 hours; 4. Take non-surgical treatment; 5. The patient has been acknowledge of the nature of the study, and volunteer to participate in the trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patient who is allergic to the drug contents or other statins; 2. Within 72 hours, required surgical treatment due to the increased bleeding; 3. Hematomas cause herniation or can be highly suspected of causing herniation, non-surgical incurable; 4. Hematoma is caused by tumors, blood diseases, arteriovenous structural lesions such as aneurysms, arteriovenous malformations and various sinus fistulas; 5. Obvious abnormal function of liver and kidney before the trial, affecting the overall prognosis of patient; 6 patient with oral statin history within 2 weeks before the experiment; 7. 4 weeks before the experiment with oral steroid patients; 8. In the past 4 weeks, taking aspirin and other antiplatelet drugs such as warfarin and other anticoagulants; 9. Patient who has participated in other drug clinical trials in 4 weeks 10. Pregnancy or lactation patients; 11. Patient with poor compliance, and cannot complete the study according to the research program; 12. The researcher finds there is any situation that is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Haematoma Absorptance Velocity;Extinction rate of edama;Changing of Neurosigns;

Secondary

MeasureTime frame
duration in the ICU;Glass Outcome Score (90 days after hospitalized);

Countries

China

Contacts

Public ContactJiang Rongcai

Tianjin Medical University General Hospital

jiang116216@163.com+86 13672116556

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026