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Timing of Cranioplasty after Craniectomy in Patients with Traumatic Brain Injury

Timing of Cranioplasty after Craniectomy in Patients with Traumatic Brain Injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002571
Enrollment
Unknown
Registered
2012-08-08
Start date
2012-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

skull defect

Interventions

ultra-early group:Cranioplasty at week4-6 after craniectomy
Three Month Group:Cranioplasty at week11-13 after craniectomy
Six Month Group:Cranioplasty at week 23-25 after craniectomy

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients at 18-60 years old inclusive, with skull defect due to craniotomy after traumatic brain injury, male or female; 2. Patients with stable vital sign, normal temperature, normal internal environment and normal heart,liver, kidney function; 3. No history of severe disease of heart,lung, liver, kidney, and digestive tract; 4. Informed consent acquried by relatives or custodians. 5. Skull defect at a convex surface with an area between 5×5cm square and 18×18cm square, no wound infection or epilepsy, being able to afford the cranioplasty.

Exclusion criteria

Exclusion criteria: 1. History of severe disease of heart, lung, liver, kidney, or digestive tract, or with history of Psychopathy; 2. Patients who have received V-P shunt; 3. Patients with abnormal temperature, unstable vital sign, or requires mechanical ventilation; 4. Patients with tracheotomy, sputum, or uncontrolled pneumonia. 5. Patients who have one of the following conditions: skull defect with a diameter less than 3cm; Persistent Vegetative State; wound infection; uncontrolled traumatic epilepsy, obvious hydrocephalus or subdural effusion

Design outcomes

Primary

MeasureTime frame
GCS scale;muscle strength;MMSE score;Language ability;GOS scale;Brain infusion (via CT perfusion);

Secondary

MeasureTime frame
morpholog;

Countries

China

Contacts

Public ContactJin Hu
hujin_dana@126.com+86 021-52887734

Outcome results

None listed

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