Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma

NCT04261673 | Active Not Recruiting DMC

• 1 other identifier: PREDICT-AEDH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Although craniotomy provides a more complete evacuation of the acute epidural hematoma, there are insufficient data to support specific surgical treatment method. We aim to perform a multi-center, parallel-group randomized clinical trial to compare the outcome and cost-effectiveness of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury patients with cerebral herniation undergoing evacuation of an acute epidural hematoma.

Conditions

Epidural Hematoma; Brain Herniation; Decompressive Craniectomy; Craniotomy

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, minimum value is 1 and maximum value is 8, which was scored as follows and higher scores mean a better outcome: 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).

  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 hospital

  within 6 months post-injury

• detailed economic evaluation

  within 6 months post-injury

• incidence of serious adverse events

  within 6 months post-injury

Study Arms (2)

Decompressive Craniectomy

EXPERIMENTAL

After the evacuation of epidural hematoma, the bone flap should not be replaced at the end of the operation.

Procedure: Decompressive Craniectomy

Craniotomy

EXPERIMENTAL

After the evacuation of epidural hematoma, the bone flap must be replaced and fixed with an appropriate fixation system.

Procedure: Craniotomy

Interventions

Decompressive Craniectomy PROCEDURE

A large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. The bone flap should not be replaced at the end of the operation. DC has an advantage in controlling brain swelling, but patient is necessary to have another operation of cranioplasty to reconstruct the skull in the future.

Decompressive Craniectomy

Craniotomy PROCEDURE

A large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. However, the bone flap must be replaced and fixed with fixation system (plates and screws). The patient will not need an additional operation to rebuild the skull in the future. But undisciplinable brain swelling and increased intracranial pressure may happen in some patients, and additional decompressive craniectomy is recommended in these cases.

Craniotomy

Eligibility Criteria

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

You may qualify if:

• Clear medical history of traumatic brain injury;
• Within 12 hours after injury;
• Unilateral mydriasis or bilateral mydriasis before the operation;
• Acute supratentorial epidural hematoma and signs of brain stem compression on CT scan, representing the leading cause of operation, despite any other minor intracranial injuries associated (e.g., subarachnoid hemorrhage and contusion);
• The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with a craniotomy or decompressive craniectomy.
• With informed consent.

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 other injuries that were deemed to be unsurvivable;
• Patients who had injury of the oculomotor nerve;
• Patients are considered to be operated mainly by following pathological change on CT: subdural hematoma, intracerebral hemorrhage, large size infarction, et al., but not because of epidural hematoma;
• 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

• RenJi Hospital: lead
• Shenzhen Second People's Hospital: collaborator
• 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

Location

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, Huang X, Feng J, Xie L, Hui J, Li W, Jiang J. Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial. Trials. 2021 Jun 29;22(1):421. doi: 10.1186/s13063-021-05359-6.

  PMID: 34187537 DERIVED

MeSH Terms

Conditions

Hematoma, Epidural, Spinal

Interventions

Decompressive Craniectomy; Craniotomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Junfeng Feng, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 10, 2020
• Study Start: May 23, 2020
• Primary Completion: September 14, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)