Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH)
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|ClinicalTrials.gov Identifier: NCT04261673|
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : February 2, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Epidural Hematoma Brain Herniation Decompressive Craniectomy Craniotomy||Procedure: Decompressive Craniectomy Procedure: Craniotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
After the evacuation of epidural hematoma, the bone flap must be replaced and fixed with an appropriate fixation system.
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.
- 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:
- 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).
- 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.
- incidence of additional craniocerebral surgery [ Time Frame: within 6 months post-injury ]Patients have additional craniocerebral surgical operation as a result of clinical deterioration.
- 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.
- 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.
- 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 hospitalization or prolongation of existing hospitalization;
- results in persistent or significant disability or incapacity;
- is otherwise considered medically significant by the investigator.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Clear medical history of traumatic brain injury;
- Within 12 hours after injury;
- Unilateral mydriasis or bilateral mydriasis before the operation;
- 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);
- The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with a craniotomy or decompressive craniectomy.
- With informed consent.
- 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.
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
|Contact: Junfeng Feng, MDemail@example.com|
|Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University||Recruiting|
|Shanghai, Shanghai, China|
|Contact: Junfeng Feng +8613611860825|
|Principal Investigator:||Junfeng Feng, MD||Department of Neurosurgery,Renji Hospital,School of Medicine,Shanghai Jiao Tong University|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||RenJi Hospital|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Hematoma, Epidural, Cranial
Hematoma, Epidural, Spinal
Pathological Conditions, Anatomical
Intracranial Hemorrhage, Traumatic
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries