Craniotomy Clinical Trial
— PORTALS-AEDHOfficial title:
A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma
This is a multicenter, prospective, and observational real-world study aimed at investigating the current situation of surgical treatments and prognosis for acute epidural hematoma in China, and analyzing the optimization of therapy.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | December 31, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Clear medical history of traumatic brain injury; 2. within 12 hours after injury; 3. Supratentorial unilateral acute epidural hematoma on first head CT scan examination; 4. The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with surgical treatment; 5. With informed consent to surgery and trial participation. Exclusion Criteria: 1. Previous intracranial surgery prior to trauma; 2. Patients with a score of 3 on the GCS, with bilateral fixed and dilated pupils, bleeding diathesis or defective coagulation, or an injury that was deemed to be unsurvivable; 3. CT demonstrates associated other intracranial hematomas e.g. subdural, intracerebral hemorrhage, or large size infarction, which are the main causes of operation; 4. Patients who had injury of the oculomotor nerve; 5. Severe pre-existing disability or severe co-morbidity which would lead to a poor outcome even if the patient is supposed to a good recovery from the TBI; 6. Pregnant female. |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital | Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shenzhen Second People's Hospital |
China,
Bullock MR, Chesnut R, Ghajar J, Gordon D, Hartl R, Newell DW, Servadei F, Walters BC, Wilberger JE; Surgical Management of Traumatic Brain Injury Author Group. Surgical management of acute epidural hematomas. Neurosurgery. 2006 Mar;58(3 Suppl):S7-15; discussion Si-iv. Review. — View Citation
Li LM, Kolias AG, Guilfoyle MR, Timofeev I, Corteen EA, Pickard JD, Menon DK, Kirkpatrick PJ, Hutchinson PJ. Outcome following evacuation of acute subdural haematomas: a comparison of craniotomy with decompressive craniectomy. Acta Neurochir (Wien). 2012 Sep;154(9):1555-61. doi: 10.1007/s00701-012-1428-8. Epub 2012 Jun 30. — View Citation
Lin H, Wang WH, Hu LS, Li J, Luo F, Lin JM, Huang W, Zhang MS, Zhang Y, Hu K, Zheng JX. Novel Clinical Scale for Evaluating Pre-Operative Risk of Cerebral Herniation from Traumatic Epidural Hematoma. J Neurotrauma. 2016 Jun 1;33(11):1023-33. doi: 10.1089/neu.2014.3656. Epub 2016 Jan 28. — View Citation
Wang WH, Hu LS, Lin H, Li J, Luo F, Huang W, Lin JM, Cai GP, Liu CC. Risk factors for post-traumatic massive cerebral infarction secondary to space-occupying epidural hematoma. J Neurotrauma. 2014 Aug 15;31(16):1444-50. doi: 10.1089/neu.2013.3142. Epub 2014 Jun 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GOSE (extended Glasgow Outcome Scale) scores | The primary outcome is indicated by the long-term functional outcomes, including overall mortality and the score on the Extended Glasgow Outcome Scale (GOS-E), "Extended Glasgow Outcome Scale" is the unabbreviated scale title. The minimum value of scale is score 1, and maximum value is scored 8, higher scores mean a better outcome and lower scores mean worse outcome. Specific scored as follows:
death; persistent vegetative state; lower severe disability; upper severe disability; (stratum 3 and 4 were considered as severe disability, with permanent requirement for help with daily living); lower moderate disability; upper moderate disability; (stratum 5 and 6 were considered as mild disability, without a need for assistance in everyday life, that might, however, require special equipment for employment); lower good recovery; upper good recovery (stratum 7 and 8 were considered as good recovery). |
at 6 months post-injury | |
Secondary | incidence of post-operative cerebral infarction | The incidence of traumatic AEDH post-operative cerebral infarction within 6 months post-injury, which is primarily diagnosed by independent radiologists with CT or MRI examination. | within 6 months post-injury | |
Secondary | incidence of additional craniocerebral surgery | The incidence of additional craniocerebral surgery within 6 months post-injury, related to clinical deterioration after initial surgical treatment of AEDH. | within 6 months post-injury | |
Secondary | length of stay in ICU and hospital | The duration of hospitalization after initial surgery within 6 months post-injury, including ICU and hospital stays. | within 6 months post-injury | |
Secondary | detailed economic evaluation | Total medical expense related to treatment of AEDH, including the costs of operations, hospitalization and rehabilitation within 6 months post-injury. | within 6 months post-injury | |
Secondary | incidence of serious adverse events | Serious adverse events (SAE) is defined as an untoward occurrence that:
results in death is life-threatening requires hospitalisation or prolongation of existing hospitalization results in persistent or significant disability or incapacity is otherwise considered medically significant by the investigator. |
within 6 months post-injury | |
Secondary | quality of life (EQ-5D-5L) | Unabbreviated scale title is "5-level EuroQol five dimensions" questionnaire. The EQ-5D is a generic instrument for describing and valuing health. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | at 6 months post-injury | |
Secondary | MMSE (mini-mental state examination) scores | MMSE (mini-mental state examination) scores at 6 months post-injury. | at 6 months post-injury |
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