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NCT Number: NCT07183540

Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery

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.

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Key information

Conditions

Cranial Defect

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anshun People's Hospital (Ward One), Anshun, Guizhou, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Decompressive craniectomy due to craniocerebral trauma, cerebral ischemia and cerebral hemorrhage.
  • Age 18 - 80 years.
  • The first time for cranial repair.
  • unilateral skull defect.
  • Compliant with recommended decompressive bone flap surgery and autogenous decompressive bone flap after bone flap collection
  • signed the informed consent.

Exclusion criteria

  • Poor healing of skin flap (active infection, non-healing, necrosis, sinus, thin or poor blood supply, etc.).
  • Fracture of bone flap ≥2 pieces, partial open fracture
  • Intracranial infection before operation.
  • Severe bone metabolic diseases.
  • Long-term use of immunosuppressants.
  • Pregnant or lactating women.
  • Coagulation disorders.
  • Severe cardiopulmonary insufficiency.
  • It is estimated that the CP process cannot be completed within 6 weeks after the bone plate decompression surgery.
  • Skull defect size less than 25cm².
  • Life expectancy less than 1 year.
  • mRS greater than 1 before primary disease.
  • Diabetic patients.
  • Patients who are unable to cooperate with follow-up assessment (e.g. mental illness).

Treatment and study plan

operation opportunity-within 6 weeks after the DC operation.

Procedure

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.

Procedure

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

Primary outcomes

  1. modified Rankin Scale (mRS) 0-2

    Time frame: at 180 (± 7) days

    The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2

Secondary outcomes

  1. mRS≤2 and mRS ≤3

    Time frame: 90 (±7) days after CP

    Proportion of mRS≤2 and proportion of mRS ≤3

  2. mRS ≤3

    Time frame: 180 (±7) days after CP

    Proportion of mRS≤2 and proportion of mRS ≤3

  3. Mini-Mental State Examination (MMSE) score

    Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery

    Minimum score 0 and maximum score 30 with higher score being better outcome

  4. Glasgow Outcome Score (GOS)

    Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery

    Minimum score 1 and maximum score 8 with higher number being better outcome

  5. hydrocephalus or Cerebrospinal fluid shunt surgery rate

    Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery

    The incidence of hydrocephalus or CSF shunt surgery

  6. Total medical expenses (excluding materials)

    Time frame: At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge

  7. Complications related medical expenses

    Time frame: At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge

  8. Incidence of infection, poor healing, and subcutaneous effusion

    Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery

  9. The incidence rate of intracranial hemorrhage

    Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery

  10. incidence of epilepsy

    Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery

  11. incidence of reoperation

    Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery

Other outcomes

  1. Overall mortality rate

    Time frame: 180 (±7) days after CP surgery

    All etiology of mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Kaya Xu

CONTACT

[email protected]

13984843194

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital Of Guizhou Medical University

Other

Registry information

Official study title

Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery: a Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study

Acronym: FAST-ECP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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