- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04229966
Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH)
A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Junfeng Feng, MD
- Phone Number: +8613611860825
- Email: fengjfmail@163.com
Study Locations
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-
Shanghai
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Shanghai, Shanghai, China
- Recruiting
- Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
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Contact:
- Junfeng Feng
- Phone Number: +8613611860825
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clear medical history of traumatic brain injury;
- within 12 hours after injury;
- Supratentorial unilateral acute epidural hematoma on first head CT scan examination;
- The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with surgical treatment;
- With informed consent to surgery and trial participation.
Exclusion Criteria:
- Previous intracranial surgery prior to trauma;
- 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;
- CT demonstrates associated other intracranial hematomas e.g. subdural, intracerebral hemorrhage, or large size infarction, which are the main causes of operation;
- Patients who had injury of the oculomotor nerve;
- 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;
- Pregnant female.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GOSE (extended Glasgow Outcome Scale) scores
Time Frame: at 6 months post-injury
|
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:
|
at 6 months post-injury
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of post-operative cerebral infarction
Time Frame: within 6 months post-injury
|
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.
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within 6 months post-injury
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incidence of additional craniocerebral surgery
Time Frame: within 6 months post-injury
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The incidence of additional craniocerebral surgery within 6 months post-injury, related to clinical deterioration after initial surgical treatment of AEDH.
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within 6 months post-injury
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length of stay in ICU and hospital
Time Frame: within 6 months post-injury
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The duration of hospitalization after initial surgery within 6 months post-injury, including ICU and hospital stays.
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within 6 months post-injury
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detailed economic evaluation
Time Frame: within 6 months post-injury
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Total medical expense related to treatment of AEDH, including the costs of operations, hospitalization and rehabilitation within 6 months post-injury.
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within 6 months post-injury
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incidence of serious adverse events
Time Frame: within 6 months post-injury
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Serious adverse events (SAE) is defined as an untoward occurrence that:
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within 6 months post-injury
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quality of life (EQ-5D-5L)
Time Frame: at 6 months post-injury
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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.
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at 6 months post-injury
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MMSE (mini-mental state examination) scores
Time Frame: at 6 months post-injury
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MMSE (mini-mental state examination) scores at 6 months post-injury.
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at 6 months post-injury
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jiyao Jiang, Professor, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Intracranial Hemorrhage, Traumatic
- Hematoma
- Hematoma, Epidural, Cranial
- Hematoma, Epidural, Spinal
Other Study ID Numbers
- PORTALS-AEDH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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