Prospective randomized evaluation of therapeutic decompressive craniectomy in severe traumatic brain injury with mass lesions (PRECIS): study protocol for a controlled trial
| Autor: | Yi Liao, Chaohua Yang, Qiang-ping Wang, He-xiang Zhao, Ding Xu, Qi Gan, Chao You |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male musculoskeletal diseases Decompressive Craniectomy medicine.medical_specialty Adolescent Intracranial pressure Traumatic brain injury medicine.medical_treatment Clinical Neurology Subdural mass lesions Severity of Illness Index law.invention Young Adult Study Protocol 03 medical and health sciences 0302 clinical medicine Clinical Protocols Randomized controlled trial law Early surgery Outcome Assessment Health Care medicine Humans 030212 general & internal medicine Cerebral perfusion pressure Craniotomy Aged Randomized Controlled Trials as Topic business.industry General Medicine Middle Aged medicine.disease Surgery Clinical trial Research Design Brain Injuries Female Decompressive craniectomy Neurology (clinical) Neurosurgery business 030217 neurology & neurosurgery |
| Zdroj: | BMC Neurology |
| ISSN: | 1471-2377 |
| DOI: | 10.1186/s12883-015-0524-9 |
| Popis: | Background For cases of severe traumatic brain injury, during primary operation, neurosurgeons usually face a dilemma of whether or not to remove the bone flap after mass lesion evacuation. Decompressive craniectomy, which involves expansion of fixed cranial cavity, is used to treat intra-operative brain swelling and post-operative malignant intracranial hypertension. However, due to indefinite indication, the decision to perform this procedure heavily relies on personal experiences. In addition, decompressive craniectomy is associated with various complications, and the procedure lacks strong evidence of better outcomes. In the present study, we designed a prospective, randomized, controlled trial to clarify the effect of decompressive craniectomy in severe traumatic brain injury patients with mass lesions. Methods PRECIS is a prospective, randomized, assessor-blind, single center clinical trial. In this trial, 336 patients with traumatic mass lesions will be randomly allocated to a therapeutic decompressive craniectomy group or a prophylactic decompressive craniectomy group. In the therapeutic decompressive craniectomy group, the bone flap will be removed or replaced depending on the emergence of brain swelling. In the prophylactic decompressive craniectomy group, the bone flap will be removed after mass lesion evacuation. A stepwise management of intracranial pressure will be provided according to the Brain Trauma Foundation guidelines. Salvage decompressive craniectomy will be performed for craniotomy patients once there is evidence of imaging deterioration and post-operative malignant intracranial hypertension. Participants will be assessed at 1, 6 and 12 months after randomization. The primary endpoint is favorable outcome according to the Extended Glasgow Outcome Score (5–8) at 12 months. The secondary endpoints include quality of life measured by EQ-5D, mortality, complications, intracranial pressure and cerebral perfusion pressure control and incidence of salvage craniectomy in craniotomy patients at each investigation time point. Discussion This study will provide evidence to optimize primary decompressive craniectomy application and assess outcomes and risks for mass lesions in severe traumatic brain injury. Trial registration ISRCTN20139421 |
| Databáze: | OpenAIRE |
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