Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery (FAST-ECP)

The Affiliated Hospital Of Guizhou Medical University

Status: Not yet enrolling

Conditions: Cranial Defect

Treatments: Procedure: operation opportunity-within 90 to 180 days after the DC operation.; Procedure: operation opportunity-within 6 weeks after the DC operation.

Study type: Interventional

Funder types: Other

Identifiers

NCT07183540

YE2025NW-140

Details and patient eligibility

About

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.

Full description

Objective:

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.

Design:

This study is a multi-center, prospective, randomized controlled, open-label trial.

Interventions:

Intervention measures were the time point of cranioplasty: within 6 weeks after decompressive craniectomy VS 3-6 months after decompressive craniectomy.

Enrollment: 582 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

582 participants in 2 patient groups

experimental group

Experimental group

Description:

The autologous skull repair surgery will be completed within 6 weeks after the DC operation.

Treatment:

Procedure: operation opportunity-within 6 weeks after the DC operation.

control group

Active Comparator group

Description:

The surgery should be completed within 90 to 180 days after DC.

Treatment:

Procedure: operation opportunity-within 90 to 180 days after the DC operation.