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AzTrials

Epidural HematomaPORTALS-AEDHNCT04229966

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

An observational study of Epidural Hematoma and Decompressive Craniectomy, run by RenJi Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
2,000 participants
Where
1 siteChina
Study dates
2 Nov 2020to 31 Dec 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The population who were diagnosed with acute epidural hematoma and necessary for undergoing evacuation of an acute epidural hematoma.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Junfeng Feng, MD contact

+8613611860825

fengjfmail@163.com

China1 site, 1 recruiting

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

    Shanghai, Shanghai Municipality

    Junfeng Feng, +8613611860825

    Recruiting

Other trials in China

About this study

Official 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.

Read the 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.

Medical subject headings
Hematoma, Epidural, Spinal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    1. death;
    2. persistent vegetative state;
    3. lower severe disability;
    4. upper severe disability; (stratum 3 and 4 were considered as severe disability, with permanent requirement for help with daily living);
    5. lower moderate disability;
    6. 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);
    7. lower good recovery;
    8. upper good recovery (stratum 7 and 8 were considered as good recovery).

    Measured: at 6 months post-injury

Secondary outcomes (7)

  1. 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.

    Measured: within 6 months post-injury

  2. 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.

    Measured: within 6 months post-injury

  3. length of stay in ICU and hospital

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

    Measured: within 6 months post-injury

  4. detailed economic evaluation

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

    Measured: within 6 months post-injury

  5. incidence of serious adverse events

    Serious adverse events (SAE) is defined as an untoward occurrence that:

    1. results in death
    2. is life-threatening
    3. requires hospitalisation or prolongation of existing hospitalization
    4. results in persistent or significant disability or incapacity
    5. is otherwise considered medically significant by the investigator.

    Measured: within 6 months post-injury

  6. 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.

    Measured: at 6 months post-injury

  7. MMSE (mini-mental state examination) scores

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

    Measured: at 6 months post-injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start2 Nov 2020
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04229966
Sponsor's protocol ID
PORTALS-AEDH
Acronym
PORTALS-AEDH
Status last verified
Jan 2026
First submitted
12 Jan 2020
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 16710967

  • 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.

    PubMed 22752713

  • 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.

    PubMed 25393339

  • 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.

    PubMed 24773559

  • 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.

    PubMed 35264341

Questions about this trial

What is this clinical trial studying?

An observational study of Epidural Hematoma and Decompressive Craniectomy, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Junfeng Feng, MD (+8613611860825, fengjfmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GOSE (extended Glasgow Outcome Scale) scores (time frame: at 6 months post-injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04229966, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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