Clinical Trials in China / NCT07183540
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Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery
NCT07183540 · tracked via the Priya Life Science China tracker
Condition(s) studied
Cranial Defect
Investigational drug(s) / intervention(s)
operation opportunity-within 6 weeks after the DC operation.operation opportunity-within 90 to 180 days after the DC operation.
operation opportunity-within 6 weeks after the DC operation.: The autologous skull repair surgery will be completed within 6 weeks after the DC operation.
operation opportunity-within 90 to 180 days after the DC operation.: The autologous skull repair surgery should be completed within 90 to 180 days after DC.
Study summary
To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3\~6 months after DC.
Eligibility
Inclusion Criteria:
1. Decompressive craniectomy due to craniocerebral trauma, cerebral ischemia and cerebral hemorrhage.
2. Age 18 - 80 years.
3. The first time for cranial repair.
4. unilateral skull defect.
5. Compliant with recommended decompressive bone flap surgery and autogenous decompressive bone flap after bone flap collection
6. signed the informed consent.
Exclusion Criteria:
1. Poor healing of skin flap (active infection, non-healing, necrosis, sinus, thin or poor blood supply, etc.).
2. Fracture of bone flap ≥2 pieces, partial open fracture
3. Intracranial infection before operation.
4. Severe bone metabolic diseases.
5. Long-term use of immunosuppressants.
6. Pregnant or lactating women.
7. Coagulation disorders.
8. Severe cardiopulmonary insufficiency.
9. It is estimated that the CP process cannot be completed within 6 weeks after the bone plate decompression surgery.
10. Skull defect size less than 25cm².
11. Life expectancy less than 1 year.
12. mRS greater than 1 before primary disease.
13. Diabetic patients.
14. Patients who are unable to cooperate with follow-up assessment (e.g. mental illness).
Primary outcome measure(s)
- modified Rankin Scale (mRS) 0-2 — at 180 (± 7) days
The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Anshun People's Hospital (Ward One) | Anshun | Guizhou | |
| Anshun People's Hospital (Ward Two) | Anshun | Guizhou | |
| The First People's Hospital of Bijie City | Bijie | Guizhou | |
| Guizhou Provincial Workers' Hospital | Guiyang | Guizhou | |
| Qianfengdong Prefecture People's Hospital | Kaili | Guizhou | |
| Zunyi Medical University Affiliated Hospital | Zunyi | Guizhou | |
| Neijiang First People's Hospital | Neijiang | Sichuan |
More The Affiliated Hospital Of Guizhou Medical University trials in China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07183540 on ClinicalTrials.gov ↗ ← All trials in China