Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04261673
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : February 2, 2021
Sponsor:
Collaborators:
Shenzhen Second People's Hospital
Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
Epidural Hematoma Brain Herniation Decompressive Craniectomy Craniotomy Procedure: Decompressive Craniectomy Procedure: Craniotomy Not Applicable

Detailed Description:
The incidence of epidural hematoma (EDH) among traumatic brain injury (TBI) patients has been reported to be in the range of 2.7 to 4%. Among patients in coma, up to 9% harbored an EDH requiring craniotomy. The mortality in patients in all age groups and GCS scores undergoing surgery for evacuation of EDH is approximately 10%. The decision to operate on an acute EDH (AEDH) is usually based on the patient's GCS score, age, pupillary abnormalities, comorbidities, CT findings, associated intracranial lesions, in delayed decisions, the time between neurological deterioration and surgery, and intracranial pressure. An AEDH greater than 30 ml should be surgically evacuated regardless of the patient's Glasgow Coma Scale (GCS) score. There are insufficient data to support one surgical treatment method. However, craniotomy provides a more complete evacuation of the hematoma for patients with an AEDH that require an operation to remove the clot. But whether decompressive craniectomy (DC) should be employed still has considerable controversy. The choice of operative technique is influenced by the surgeon's expertise, training, and evaluation of a particular situation. The difference between these two procedures is that a bone flap is left out before closing the skin in DC. Both approaches are widely used among neurological surgeons (although the indications may differ), therefore there is sufficient experience in the centers to set up a randomized clinical trial.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Evaluate Decompressive Craniectomy for Patients With Cerebral Herniation Undergoing Evacuation of Acute Epidural Hematoma
Actual Study Start Date : May 23, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Decompressive Craniectomy
After the evacuation of epidural hematoma, the bone flap should not be replaced at the end of the operation.
Procedure: Decompressive Craniectomy
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.

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




Primary Outcome Measures :
  1. GOSE (extended Glasgow Outcome Scale) scores [ Time Frame: 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, 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).


Secondary Outcome Measures :
  1. incidence of post-operative cerebral infarction [ Time Frame: within 6 months post-injury ]
    Patients have clinical deterioration after an initial surgery because of post-operative cerebral infarction.

  2. incidence of additional craniocerebral surgery [ Time Frame: within 6 months post-injury ]
    Patients have additional craniocerebral surgical operation as a result of clinical deterioration.

  3. length of stay in hospital [ Time Frame: within 6 months post-injury ]
    The length of patient's stay in hospital after initial surgery, which must due to AEDH related medical treatment. Number of days in hospital are used to evaluate length, and patients with poor treatment effect may need longer 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. Different operations have different medical expense,and patients with poor treatment effect may need more medical expense. We record and evaluate the total medical expense of the entire AEDH treatment process, 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:

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

  6. quality of life (EQ-5D-5L) [ Time Frame: at 1,3 and 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 1,3 and 6 months post-injury ]
    Unabbreviated scale title is "mini-mental state examination", and minimum value is 0 and maximum value is 30. Higher scores mean a better outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clear medical history of traumatic brain injury;
  2. Within 12 hours after injury;
  3. Unilateral mydriasis or bilateral mydriasis before the operation;
  4. Supratentorial acute epidural hematoma on CT scan with midline shift, which is the leading cause of operation, despite associated other lighter intracranial injury (e.g., subarachnoid hemorrhage and contusion);
  5. The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with a craniotomy or decompressive craniectomy.
  6. With informed consent.

Exclusion Criteria:

  1. Previous intracranial surgery prior to trauma;
  2. 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;
  3. Patients who had injury of the oculomotor nerve;
  4. 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;
  5. 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;
  6. Pregnant female.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261673


Contacts
Layout table for location contacts
Contact: Junfeng Feng, MD +8613611860825 fengjfmail@163.com

Locations
Layout table for location information
China, Shanghai
Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China
Contact: Junfeng Feng    +8613611860825      
Sponsors and Collaborators
RenJi Hospital
Shenzhen Second People's Hospital
Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Junfeng Feng, MD Department of Neurosurgery,Renji Hospital,School of Medicine,Shanghai Jiao Tong University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04261673    
Other Study ID Numbers: PREDICT-AEDH
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematoma, Epidural, Cranial
Hematoma
Hernia
Hematoma, Epidural, Spinal
Hemorrhage
Pathologic Processes
Pathological Conditions, Anatomical
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries