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A multicenter and randomized controlled trial for dexamethasone combined with atorvastatin in the treatment of spontaneous intracerebral parenchymal hematoma

A multicenter and randomized controlled trial for dexamethasone combined with atorvastatin in the treatment of spontaneous intracerebral parenchymal hematoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016521
Enrollment
Unknown
Registered
2018-06-06
Start date
2018-06-10
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

erebral Hemorrhage

Interventions

Atorvastatin:Atorvastatin(20mg,Qd,Oral)4 weeks
Atorvastatin&Dexamethasone:Atorvastatin&Dexamethasone

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged =18 years, male and female; 2. GCS> 8, head CT or MRI clearly shows spontaneous, solitary, localized intracerebral hematoma in the basal ganglia (Patients with hematoma volume of 15ml-40ml who were unable to tolerate surgery or refused surgical treatment due to poor function of large organs); 3. Hematoma occurs less than 48 hours; 4. Patients with no risk of brain hernia are suitable for 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; 2. Within 72 hours, required surgical treatment due to the increased bleeding; 3. Breaking into the ventricle or communicating with the subarachnoid space and cerebrospinal fluid circulation; 4. Hematomas cause herniation or can be highly suspected of causing herniation, non-surgical incurable; 5. Hematoma is caused by tumors, blood diseases, suspected vascular amyloidosis, arteriovenous structural lesions such as aneurysms, arteriovenous malformations and various sinus fistulas; 6. Patients with previous cerebral hemorrhage and neurological dysfunction caused by cerebral infarction; 7. Obvious abnormal function of liver and kidney before the trial, affecting the overall prognosis of patient; 8. Patients with a history of oral or allergic statins during the first 2 weeks of the trial; 9. 4 weeks before the experiment with oral steroid patients; 10. Those diagnosed with diabetes or who have sustained blood sugar levels greater than 10mmol/l ; 11. Use of antiplatelet drugs such as aspirin or warfarin in the last 4 weeks; 12. Patient who has participated in other drug clinical trials in 4 weeks 13. Pregnancy or lactation patients; 14. Patient with poor compliance, and cannot complete the study according to the research program; 15. 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 ;

Secondary

MeasureTime frame
NIHSS Score;Glasgow Coma Scale;ADL-BI;Glass Outcome Score;trans - operation rate;

Countries

China

Contacts

Public ContactRongcai Jiang

Tianjin Medical University General Hospital

jiang116216@163.com+86 13672116556

Outcome results

None listed

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