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

NCT04229966 | Recruiting DMC

• 1 other identifier: PORTALS-AEDH
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompressive Craniectomy; Craniotomy; Epidural Hematoma

Outcome Measures

Primary Outcomes (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).

  at 6 months post-injury

Secondary Outcomes (7)

• incidence of post-operative cerebral infarction

  within 6 months post-injury

• incidence of additional craniocerebral surgery

  within 6 months post-injury

• length of stay in ICU and hospital

  within 6 months post-injury

• detailed economic evaluation

  within 6 months post-injury

• incidence of serious adverse events

  within 6 months post-injury

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 16710967 BACKGROUND

• 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.

  PMID: 22752713 BACKGROUND

• 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.

  PMID: 25393339 BACKGROUND

• 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.

  PMID: 24773559 BACKGROUND

• 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.

  PMID: 35264341 DERIVED

MeSH Terms

Conditions

Hematoma, Epidural, Spinal

Condition Hierarchy (Ancestors)

Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiyao Jiang, Professor

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Junfeng Feng, MD

CONTACT

+8613611860825; fengjfmail@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 18, 2020
• Study Start: November 2, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CN (1)