The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders

NCT02192320 | Unknown Phase 2

• 1 other identifier: CSDH2014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders

Conditions

Chronic Subdural Hematoma

Keywords

Atorvastatin; Atorvastatin and Dexamethasone; Chronic Subdural Hematoma; conservative treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  2,5,12 weeks during treatment

Secondary Outcomes (5)

• Outcome score (GOSE) in subjects

  2,5,12 weeks during treatment

• Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis

  2,5,12 weeks during treatment

• Changes of neurological symptoms and signs

  2,5,12 weeks during treatment

• Recurrence and prognosis of patient failure in those conservative treatment

  2,5,12 weeks during treatment

• Outcome score (ADL-BI Scale) in subjects

  2,5,12 weeks during treatment

Study Arms (2)

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)

Drug: Atorvastatin and Dexamethasone

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin: 20 mg (every evening orally) for 5 weeks

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

20 mg (every evening orally) for 5 weeks

Atorvastatin

Atorvastatin and Dexamethasone DRUG

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)

Atorvastatin and Dexamethasone

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Oriental Neurosurgery Evidence-Based-Study Team: lead

Study Sites (2)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Atorvastatin; Dexamethasone

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Rongcai Jiang, PhD

CONTACT

86-22-60814348; jianghope@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 16, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

CN (2)