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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• modified Rankin Scale (mRS) 0-2 [Срок оценки: at 180 (± 7) days]

Вторичные конечные точки (11)

• mRS≤2 and mRS ≤3 [Срок оценки: 90 (±7) days after CP]
• mRS ≤3 [Срок оценки: 180 (±7) days after CP]
• Mini-Mental State Examination (MMSE) score [Срок оценки: 90 days (±7 days) and 180 days (±7 days) after CP surgery]
• Glasgow Outcome Score (GOS) [Срок оценки: 90 days (±7 days) and 180 days (±7 days) after CP surgery]
• hydrocephalus or Cerebrospinal fluid shunt surgery rate [Срок оценки: 90 days (±7 days) and 180 days (±7 days) after CP surgery]
• Total medical expenses (excluding materials) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 90 days (±7 days) and 180 days (±7 days) after CP surgery]
• The incidence rate of intracranial hemorrhage [Срок оценки: 90 days (±7 days) and 180 days (±7 days) after CP surgery]
• incidence of epilepsy [Срок оценки: 90 days (±7 days) and 180 days (±7 days) after CP surgery]
• incidence of reoperation [Срок оценки: 90 days (±7 days) and 180 days (±7 days) after CP surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Anshun People's Hospital (Ward One) — Anshun
• Anshun People's Hospital (Ward Two) — Anshun
• The First People's Hospital of Bijie City — Bijie
• Guizhou Provincial Workers' Hospital — Guiyang
• Qianfengdong Prefecture People's Hospital — Kaili
• Zunyi Medical University Affiliated Hospital — Zunyi
• Neijiang First People's Hospital — Neijiang

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 16965895

Идентификаторы

NCT: NCT07183540 · YE2025NW-140

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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