Cranial DefectFAST-ECPNCT07183540

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

A study testing operation opportunity-within 6 weeks after the DC operation. and operation opportunity-within 90 to 180 days after the DC operation. in people with Cranial Defect, run by The Affiliated Hospital Of Guizhou Medical University at 7 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Cranial Defect
What is being tested?: operation opportunity-within 6 weeks after the DC operation. and operation opportunity-within 90 to 180 days after the DC operation.
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 582 participants
Where: 7 sitesChina
Study dates: 1 Oct 2025to 1 Sep 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 14Show fewer

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).

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kaya Xu contact

13984843194

xkaya@sina.com

City, postcode or hospital

7 sites in 1 country

China7 sites

Anshun People's Hospital (Ward One)
Anshun, Guizhou, 561000
Wenyuan Tang, MM, 13985312332, 13985312332@qq.com
Anshun People's Hospital (Ward Two)
Anshun, Guizhou, 561000
Hui Shuai, BMed, 13985729194, 13985729194@qq.com
The First People's Hospital of Bijie City
Bijie, Guizhou
Bingxiang Xiao, MD
Guizhou Provincial Workers' Hospital
Guiyang, Guizhou
Guanghui Ran, BMed, 18286059351, 18286059351@qq.com
Qianfengdong Prefecture People's Hospital
Kaili, Guizhou
Jian Shen, MM, 15985527337, 15985527337@qq.com
Neijiang First People's Hospital
Neijiang, Sichuan
Cong Liu, 13438640683, 13438640683@qq.com
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou
Haitao Wu, 18984980327, 18984980327@qq.com

Other trials in China

About this study

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

Read the detailed description

Objective:

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.

Conditions: Cranial Defect
Being tested: operation opportunity-within 6 weeks after the DC operation., operation opportunity-within 90 to 180 days after the DC operation.
Keywords: Decompressive craniectomy and Cranioplasty, operation opportunity, ultra-early, Autologous skull

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

operation opportunity-within 6 weeks after the DC operation.Procedure or 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 or surgery
The autologous skull repair surgery should be completed within 90 to 180 days after DC.

Study groups in NCT07183540
Study group	Role	What they receive
experimental group	Experimental	The autologous skull repair surgery will be completed within 6 weeks after the DC operation. Receives: Procedure: operation opportunity-within 6 weeks after the DC operation.
control group	Active comparator	The surgery should be completed within 90 to 180 days after DC. Receives: Procedure: operation opportunity-within 90 to 180 days after the DC operation.

What is being measured

The primary outcome is the main question the study is designed to answer.

modified Rankin Scale (mRS) 0-2
The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2
Measured: at 180 (± 7) days

Secondary outcomes (11)

mRS≤2 and mRS ≤3
Proportion of mRS≤2 and proportion of mRS ≤3
Measured: 90 (±7) days after CP
mRS ≤3
Proportion of mRS≤2 and proportion of mRS ≤3
Measured: 180 (±7) days after CP
Mini-Mental State Examination (MMSE) score
Minimum score 0 and maximum score 30 with higher score being better outcome
Measured: 90 days (±7 days) and 180 days (±7 days) after CP surgery
Glasgow Outcome Score (GOS)
Minimum score 1 and maximum score 8 with higher number being better outcome
Measured: 90 days (±7 days) and 180 days (±7 days) after CP surgery
hydrocephalus or Cerebrospinal fluid shunt surgery rate
The incidence of hydrocephalus or CSF shunt surgery
Measured: 90 days (±7 days) and 180 days (±7 days) after CP surgery
Total medical expenses (excluding materials)
Measured: At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge
Complications related medical expenses
Measured: At the time of discharge from CP, 90 (±7) days after CP-CP and 180 (±7) days after CP-CP at discharge
Incidence of infection, poor healing, and subcutaneous effusion
Measured: 90 days (±7 days) and 180 days (±7 days) after CP surgery
The incidence rate of intracranial hemorrhage
Measured: 90 days (±7 days) and 180 days (±7 days) after CP surgery
incidence of epilepsy
Measured: 90 days (±7 days) and 180 days (±7 days) after CP surgery
incidence of reoperation
Measured: 90 days (±7 days) and 180 days (±7 days) after CP surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20251 Sep 2027

First posted19 Sep 2025
Study start1 Oct 2025 (estimated)
Primary completion1 Sep 2027 (estimated)
Study completion1 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Cranial DefectStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 582 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07183540
Sponsor's protocol ID: YE2025NW-140
Acronym: FAST-ECP
Status last verified: Sep 2025
First submitted: 11 Sep 2025
Last updated: 19 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Interested in taking part?

Kaya Xu

13984843194

xkaya@sina.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Cranial Defect trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery: a Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
ClinicalTrials.gov ID: NCT07183540
Acronym / sponsor ID: FAST-ECP / YE2025NW-140
Conditions: Cranial Defect
Keywords: Decompressive craniectomy and Cranioplasty, operation opportunity, ultra-early, Autologous skull
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 582 participants (estimated)
Lead sponsor: The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
Study start: 1 Oct 2025 (estimated)
Primary completion: 1 Sep 2027 (estimated)
Study completion: 1 Sep 2027 (estimated)
First posted: 19 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective:

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Procedure: operation opportunity-within 6 weeks after the DC operation.The autologous skull repair surgery will be completed within 6 weeks after the DC operation.
control group	Active comparator	Procedure: operation opportunity-within 90 to 180 days after the DC operation.The surgery should be completed within 90 to 180 days after DC.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
operation opportunity-within 6 weeks after the DC operation.The autologous skull repair surgery will be completed within 6 weeks after the DC operation.	Procedure or surgery	experimental group
operation 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.	Procedure or surgery	control group

Primary outcome

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

11 secondary outcomes

mRS≤2 and mRS ≤3
Time frame: 90 (±7) days after CP
mRS ≤3
Time frame: 180 (±7) days after CP
Mini-Mental State Examination (MMSE) score
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
Glasgow Outcome Score (GOS)
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
hydrocephalus or Cerebrospinal fluid shunt surgery rate
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
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
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
Incidence of infection, poor healing, and subcutaneous effusion
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
The incidence rate of intracranial hemorrhage
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
incidence of epilepsy
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery
incidence of reoperation
Time frame: 90 days (±7 days) and 180 days (±7 days) after CP surgery

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
Background: PubMed 28799868Morton 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.
Background: PubMed 35061995Eaton 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.
Background: PubMed 33423107Mirabet 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.
Background: PubMed 23140156Piedra 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.
Background: PubMed 28419358Malcolm 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.
Background: PubMed 23933129Huang 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.
Background: PubMed 16077318Yamada 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.
Background: PubMed 16965895Hokugo 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.
Background: PubMed 19427221Martin 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.
Background: PubMed 19485722Gooch 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.
Background: PubMed 12621197Taub 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.
Background: PubMed 30768137Lilja-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.
Individual participant dataSharing planned: No

Related trials for Cranial Defect

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Kaya Xu contact

13984843194

xkaya@sina.com

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kaya Xu (13984843194, xkaya@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin Scale (mRS) 0-2 (time frame: at 180 (± 7) days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07183540, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.