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NCT Number: NCT04229966

Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Junfeng Feng

CONTACT

+8613611860825

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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:

    • 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).

Secondary outcomes

  1. 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.

  2. incidence of additional craniocerebral surgery

    Time frame: within 6 months post-injury

    The incidence of additional craniocerebral surgery within 6 months post-injury, related to clinical deterioration after initial surgical treatment of AEDH.

  3. length of stay in ICU and hospital

    Time frame: within 6 months post-injury

    The duration of hospitalization after initial surgery within 6 months post-injury, including ICU and hospital stays.

  4. detailed economic evaluation

    Time frame: within 6 months post-injury

    Total medical expense related to treatment of AEDH, including the costs of operations, hospitalization and rehabilitation within 6 months post-injury.

  5. incidence of serious adverse events

    Time frame: within 6 months post-injury

    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.
  6. quality of life (EQ-5D-5L)

    Time frame: at 6 months post-injury

    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.

  7. MMSE (mini-mental state examination) scores

    Time frame: at 6 months post-injury

    MMSE (mini-mental state examination) scores at 6 months post-injury.

Study contacts

Contact information is provided by the study sponsor or research team.

Junfeng Feng, MD

CONTACT

[email protected]

+8613611860825

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
  • Shenzhen Second People's Hospital

Registry information

Official study title

A Real World, Multicenter, Prospective, Observational Study to Compare Effectiveness of Surgical Treatments in Patients With Acute Epidural Hematoma

Acronym: PORTALS-AEDH

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2020
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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