Clinical trial NCT04229966: Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases
Official title: A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epidural Hematoma
Decompressive Craniectomy
Craniotomy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
name: Shenzhen Second People's Hospital
First posted: 2020-01-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population who were diagnosed with acute epidural hematoma and necessary for undergoing evacuation of an acute epidural hematoma.

Brief summary: 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.

Detailed description: The incidence of Acute Epidural Hematoma (AEDH) among traumatic brain injury (TBI) patients has been reported to be in the range of 2.7 to 4%. The mortality in patients in all age groups and GCS scores undergoing surgery for evacuation of EDH is approximately 10%.

Most people with EDH are generally expected to have a good clinical outcome with the prompt and correct treatment. However, AEDH still represents a potentially life-threatening condition when a local mass effect exists due to rapidly elevated intracranial pressure (ICP) resulted from the rapid build-up of blood. Brain hernia and cerebral infarction might occur and lead to a terrible clinical outcome. In addition, there is a set of patients who experience clinical deterioration after an initial hematoma-evacuation craniotomy because of secondary brain injuries, including massive cerebral infarction (MCI), additional decompressive craniectomy is recommended as soon as possible.

Although DC can reduce the morbidity and mortality in critically ill patients with a sTBI, the removal of the bone flap is not necessary for the majority of patients with AEDH, because of the relatively low incidence of MCI secondary to AEDH. Recommendations indicated an epidural hematoma greater than 30 ml should be surgically evacuated regardless of the patient's GCS score. Although craniotomy provides a complete evacuation to remove the clot of the hematoma, there are insufficient data to support a specific surgical treatment method. The choice of operative technique is influenced by the surgeon's expertise, training, and evaluation of a particular situation. Therefore, there is a clinical rationale for investigating the current status of surgical treatments and prognosis for AEDH, thereby providing a reliable reference for the optimization of therapy.

Eligibility criteria: 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.

Primary outcomes:
measure: GOSE (extended Glasgow Outcome Scale) scores
timeFrame: at 6 months post-injury
Secondary outcomes:
measure: incidence of post-operative cerebral infarction
timeFrame: within 6 months post-injury
measure: incidence of additional craniocerebral surgery
timeFrame: within 6 months post-injury
measure: length of stay in ICU and hospital
timeFrame: within 6 months post-injury
measure: detailed economic evaluation
timeFrame: within 6 months post-injury
measure: incidence of serious adverse events
timeFrame: within 6 months post-injury
measure: quality of life (EQ-5D-5L)
timeFrame: at 6 months post-injury
measure: MMSE (mini-mental state examination) scores
timeFrame: at 6 months post-injury
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Jiyao Jiang, Professor
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
citation: Yang C, Hui J, Xie L, Feng J, Jiang J. Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH). BMJ Open. 2022 Mar 9;12(3):e051247. doi: 10.1136/bmjopen-2021-051247.