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Not yet recruitingNCT07183540FAST-ECPUpdated Sep 19, 2025

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

An interventional study of operation opportunity-within 6 weeks after the DC operation. and operation opportunity-within 90 to 180 days after the DC operation. in Cranial Defect, sponsored by The Affiliated Hospital Of Guizhou Medical University. Not yet recruiting at 7 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by The Affiliated Hospital Of Guizhou Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
582
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Cranial Defect

Keywords

  • Decompressive craniectomy and Cranioplasty
  • operation opportunity
  • ultra-early
  • Autologous skull
03

In context

Lead sponsor

The Affiliated Hospital Of Guizhou Medical University is the lead sponsor of 15 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
582 participants (estimated)

Study arms

  • Experimental
    experimental group

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

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

  • Active comparator
    control group

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

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

Interventions

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

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

  • Procedureoperation 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.

06

What researchers measure

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

  5. hydrocephalus or Cerebrospinal fluid shunt surgery rate

    The incidence of hydrocephalus or CSF shunt surgery

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

    All etiology of mortality

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

07

Study locations

7 sites
  • Anshun People's Hospital (Ward One)
    Anshun, Guizhou 561000, China
  • Anshun People's Hospital (Ward Two)
    Anshun, Guizhou 561000, China
  • The First People's Hospital of Bijie City
    Bijie, Guizhou, China
    • Bingxiang Xiao, MD · Contact
  • Guizhou Provincial Workers' Hospital
    Guiyang, Guizhou, China
  • Qianfengdong Prefecture People's Hospital
    Kaili, Guizhou, China
  • Zunyi Medical University Affiliated Hospital
    Zunyi, Guizhou, China
  • Neijiang First People's Hospital
    Neijiang, Sichuan, China
08

References and documents

Publications

  • Morton RP, Abecassis IJ, Hanson JF, Barber JK, Chen M, Kelly CM, Nerva JD, Emerson SN, Ene CI, Levitt MR, Chowdhary MM, Ko AL, Chesnut RM. Timing of cranioplasty: a 10.75-year single-center analysis of 754 patients. J Neurosurg. 2018 Jun;128(6):1648-1652. doi: 10.3171/2016.11.JNS161917. Epub 2017 Aug 11. PubMed 28799868 ↗
  • Eaton JC, Greil ME, Nistal D, Caldwell DJ, Robinson E, Aljuboori Z, Temkin N, Bonow RH, Chesnut RM. Complications associated with early cranioplasty for patients with traumatic brain injury: a 25-year single-center analysis. J Neurosurg. 2022 Jan 21;137(3):776-781. doi: 10.3171/2021.11.JNS211557. Print 2022 Sep 1. PubMed 35061995 ↗
  • Mirabet V, Garcia D, Yague N, Larrea LR, Arbona C, Botella C. The storage of skull bone flaps for autologous cranioplasty: literature review. Cell Tissue Bank. 2021 Sep;22(3):355-367. doi: 10.1007/s10561-020-09897-2. Epub 2021 Jan 9. PubMed 33423107 ↗
  • Piedra MP, Ragel BT, Dogan A, Coppa ND, Delashaw JB. Timing of cranioplasty after decompressive craniectomy for ischemic or hemorrhagic stroke. J Neurosurg. 2013 Jan;118(1):109-14. doi: 10.3171/2012.10.JNS121037. Epub 2012 Nov 9. PubMed 23140156 ↗
  • Malcolm JG, Rindler RS, Chu JK, Chokshi F, Grossberg JA, Pradilla G, Ahmad FU. Early Cranioplasty is Associated with Greater Neurological Improvement: A Systematic Review and Meta-Analysis. Neurosurgery. 2018 Mar 1;82(3):278-288. doi: 10.1093/neuros/nyx182. PubMed 28419358 ↗
  • Huang YH, Lee TC, Yang KY, Liao CC. Is timing of cranioplasty following posttraumatic craniectomy related to neurological outcome? Int J Surg. 2013;11(9):886-90. doi: 10.1016/j.ijsu.2013.07.013. Epub 2013 Aug 7. PubMed 23933129 ↗
  • Yamada A, Imai K, Nomachi T, Fujimoto T, Sakamoto H, Kitano S. Cranial distraction for plagiocephaly: quantitative morphologic analyses of cranium using three-dimensional computed tomography and a life-size model. J Craniofac Surg. 2005 Jul;16(4):688-93. doi: 10.1097/01.scs.0000168995.27882.66. PubMed 16077318 ↗
  • Hokugo A, Sawada Y, Sugimoto K, Fukuda A, Mushimoto K, Morita S, Tabata Y. Preparation of prefabricated vascularized bone graft with neoangiogenesis by combination of autologous tissue and biodegradable materials. Int J Oral Maxillofac Surg. 2006 Nov;35(11):1034-40. doi: 10.1016/j.ijom.2006.06.003. Epub 2006 Sep 11. PubMed 16965895 ↗
  • Martin MP, Olson S. Post-operative complications with titanium mesh. J Clin Neurosci. 2009 Aug;16(8):1080-1. doi: 10.1016/j.jocn.2008.07.087. Epub 2009 May 7. PubMed 19427221 ↗
  • Gooch MR, Gin GE, Kenning TJ, German JW. Complications of cranioplasty following decompressive craniectomy: analysis of 62 cases. Neurosurg Focus. 2009 Jun;26(6):E9. doi: 10.3171/2009.3.FOCUS0962. PubMed 19485722 ↗
  • Taub PJ, Rudkin GH, Clearihue WJ 3rd, Miller TA. Prefabricated alloplastic implants for cranial defects. Plast Reconstr Surg. 2003 Mar;111(3):1233-40. doi: 10.1097/01.PRS.0000046048.77472.23. No abstract available. PubMed 12621197 ↗
  • Lilja-Cyron A, Andresen M, Kelsen J, Andreasen TH, Fugleholm K, Juhler M. Long-Term Effect of Decompressive Craniectomy on Intracranial Pressure and Possible Implications for Intracranial Fluid Movements. Neurosurgery. 2020 Feb 1;86(2):231-240. doi: 10.1093/neuros/nyz049. PubMed 30768137 ↗
  • Winkler PA, Stummer W, Linke R, Krishnan KG, Tatsch K. Influence of cranioplasty on postural blood flow regulation, cerebrovascular reserve capacity, and cerebral glucose metabolism. J Neurosurg. 2000 Jul;93(1):53-61. doi: 10.3171/jns.2000.93.1.0053. PubMed 10883905 ↗
  • Kuo JR, Wang CC, Chio CC, Cheng TJ. Neurological improvement after cranioplasty - analysis by transcranial doppler ultrasonography. J Clin Neurosci. 2004 Jun;11(5):486-9. doi: 10.1016/j.jocn.2003.06.005. PubMed 15177389 ↗
  • Yamaura A, Makino H. Neurological deficits in the presence of the sinking skin flap following decompressive craniectomy. Neurol Med Chir (Tokyo). 1977;17(1 Pt 1):43-53. doi: 10.2176/nmc.17pt1.43. No abstract available. PubMed 74031 ↗
  • Hutchinson PJ, Kolias AG, Timofeev IS, Corteen EA, Czosnyka M, Timothy J, Anderson I, Bulters DO, Belli A, Eynon CA, Wadley J, Mendelow AD, Mitchell PM, Wilson MH, Critchley G, Sahuquillo J, Unterberg A, Servadei F, Teasdale GM, Pickard JD, Menon DK, Murray GD, Kirkpatrick PJ; RESCUEicp Trial Collaborators. Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension. N Engl J Med. 2016 Sep 22;375(12):1119-30. doi: 10.1056/NEJMoa1605215. Epub 2016 Sep 7. PubMed 27602507 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07183540
Lead sponsor
The Affiliated Hospital Of Guizhou Medical University
Responsible party
Kaya Xu (Principal Investigator, The Affiliated Hospital Of Guizhou Medical University) — Principal investigator
First posted
Sep 19, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Sep 19, 2025

Study contacts

Kaya Xu
Contact
xkaya@sina.com
13984843194

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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