Health TrialsbyHealthPanel

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

ConditionCranial Defect
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Affiliated Hospital Of Guizhou Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Decompressive craniectomy due to craniocerebral trauma, cerebral ischemia and cerebral hemorrhage.

Age 18 - 80 years.

The first time for cranial repair.

unilateral skull defect.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • operation opportunity-within 6 weeks after the DC operation.

    Procedure/Surgery

    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/Surgery

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

Treatment groups

582 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

modified Rankin Scale (mRS) 0-2

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

Time frame
at 180 (± 7) days

Secondary outcomes

1

mRS≤2 and mRS ≤3

Proportion of mRS≤2 and proportion of mRS ≤3

Time frame
90 (±7) days after CP
2

mRS ≤3

Proportion of mRS≤2 and proportion of mRS ≤3

Time frame
180 (±7) days after CP
3

Mini-Mental State Examination (MMSE) score

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

Time frame
90 days (±7 days) and 180 days (±7 days) after CP surgery
4

Glasgow Outcome Score (GOS)

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

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

Other outcomes

1

Overall mortality rate

All etiology of mortality

Time frame
180 (±7) days after CP surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Hospital Of Guizhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: