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The clinical proof-of-concept study of Craniocervical Manual Lymphatic massage for chronic subdural hematoma

The clinical proof-of-concept study of Craniocervical Manual Lymphatic massage for chronic subdural hematoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093100
Enrollment
Unknown
Registered
2024-11-28
Start date
2024-11-29
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Chronic subdural hematoma

Interventions

Medical treatment :Medical treatments include Atorvastatin (20mg per day) and Dexamethasone placebo (0.75mg tid for 2 weeks, bid for 1 week, qd for 1 week), total 4 weeks treatment
Medical treatment combined with manual lymphatic drainage:Besides the medical treatment, patients will receive manual lymphatic drainage(Craniocervical Manual Lymphatic massage) five times a day

Sponsors

Tianjin Medical University General Hosptial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 90 years old, male and female; 2. Within 72 hours before enrollment in the experiment, CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult); a single unilateral hematoma should be greater than 10ml; 3. Modified Rankin Scale (mRS) 1~3 Grade (including 1 and 3); 4. 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; 5.Patients fully understood the nature of the study, and voluntarily participates and signs informed consent

Exclusion criteria

Exclusion criteria: 1. Allergic to the statin, Glucocorticoid or its ingredients; 2. Cerebral herniation might occur at any time or highly suspected severe hernia, and surgery must be performed to exclude dangerous situation; 3. Hematoma caused by tumors, hematologic diseases, Tuberculous, arachnoid cyst, vascular malformation, ventricular peritoneal shunt or other known severe comorbidities; 4. Abnormal liver function, hepatitis or uncontrolled liver diseases, as well as suffering from other disease may interfere the study; 5. Severe cardiac, pulmonary, hepatic and renal dysfunction were observed before admission, which affected the prognosis of the patients; 6. Diabetes with poorly controlled, blood glucose continues to exceed 10mmol/L; 7. Have a history of femoral head necrosis with no surgery; 8. In the past 4 weeks, patients with a history of oral statins or allergic reactions to statins were present; 9. In the past 4 weeks, patients with a history of using steroid hormone; 10. In the past 4 weeks, patients have been on anticoagulants such as warfarin or obviously abnormal coagulation function; 11. Participate in other clinical trials in the past four weeks; 12. Pregnant or breastfeeding; 13.Cervical lymphadenectasis, skin injury and infection; 14.Patients with dementia and other disorders affecting cognitive function 15. Failure of completing the trial by poor compliance; 16. For any reason, the researchers believe that the case is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Neurological function;function of mLV;

Secondary

MeasureTime frame
volume change of hematoma;MoCA;mRS score;

Countries

China

Contacts

Public ContactRongcai Jiang/Chuang Gao

Tianjin Medical University General Hosptial

chuang888999@126.com+86 132 1216 2881

Outcome results

None listed

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