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Multicenter, Randomized and Double-blind Controlled Clinical Trial of Atorvastatin for Treatment of Chronic Subdural Hematoma

Multicenter, Randomized and Double-blind Controlled Clinical Trial of Atorvastatin for Treatment of Chronic Subdural Hematoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002328
Enrollment
Unknown
Registered
2012-03-21
Start date
2012-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chronic Subdural Hematoma

Interventions

A1:Oral atorvastatin regimen continued
A2:Patients were done drilling hematoma drainage when
A3:Postoperative large rehydration treatment
A4:Moderate drop cranial pressure treatment according
P1:Oral placebo
P2:Patients were done drilling hematoma drainage when accord with the standard of operation
P3:Postoperative large rehydration treatment
P4:Moderate drop cranial pressure treatment according to patients condition

Sponsors

Tianjin medical university general hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. age > 45 years old, male or female; 2. chronic subdural hematoma is located in the upward transtentorial cerebellum; 3. liver function have no obvious abnormity; 4. Should the surgery, the researchers judge whether accord with neural surgical indications; 5. Should the surgery, preoperative Hb, PLT, PT, INR and APTT reach surgical indications; 6. patients have fully understand the the study, voluntary take the test and informed agreement signed.

Exclusion criteria

Exclusion criteria: 1. patients who have known allergy and allergic constitution on this study drug ingredients; 2. hematoma is caused by tumor, and hematologic diseases; 3. hepatitis and liver disease not get controlled, and other diseases or assessment the researchers think that may interfere with in the study; 4. have taken part in other drugs research in nearly four weeks; 5. not take the drilling drainage, and in the perioperative using hemostatic agents or (and) other drugs in hematoma cavity, postoperative drainage less than 24 hours or not drainage enough, and postoperative infections occurred; 6. Definite diagnosis in patients with chronic subdural effusion, the symptoms and signs are stable six months or more; 7. compliance is bad, the research for the researcher can not be complete; 8. for any reason, the researchers think any not suitable for the situation was.

Design outcomes

Primary

MeasureTime frame
the quantity change on CT before and after treatment;Huge hematoma group main observation preoperative;

Secondary

MeasureTime frame
the symptoms improve before and after every stage;Blood routine before and after every stage treatment;Liver function before and after every stage treatment;Blood coagulation function;GOS prognostic score;Daily life ability score (ADL score);

Countries

China

Contacts

Public ContactJianning Zhang
jianningzhang@hotmail.com+86 13820388822

Outcome results

None listed

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