Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care
A Randomized Controlled Clinical Study on Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care Patients
1 other identifier
interventional
80
1 country
1
Brief Summary
Enhanced recovery after surgery (ERAS) is a strategy of perioperative management aimed to accelerate the rehabilitation of patients through various optimized perioperative managements as well as ongoing adherence to a patient-focused, multidisciplinary, and multimodal approach. Alleviating the injury and stress caused by surgery or disease is the core principle of ERAS, which has been shown to reduce complication rates after surgery, promote patient recovery, decrease hospital length of stay and reduce costs. ERAS has been widely applied in many surgical perioperative fields, and it has achieved remarkable effects. However, there are few applications of ERAS in neurosurgery, especially in clinical trials of neurocritical care patients. Therefore, the investigators attempt to conduct the study of ERAS in neurosurgical intensive patients using a series of optimized perioperative managements that have been verified to be effective by evidence-based medicine, and to evaluate the safety and effectiveness of ERAS in neurocritical care. The aim of this study is to explore the most suitable ERAS protocols to accelerate the postoperative rehabilitation process of neurocritical care patients, and to provide more evidence-based medicine for the effectiveness and safety of ERAS in neurosurgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedStudy Start
First participant enrolled
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
March 4, 2025
March 1, 2025
2.5 years
January 20, 2024
March 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical prognosis
Glasgow Outcome Scale score (1 = death; 2 = persistent vegetative state; 3 = severe disability; 4 = moderate disability; 5 = good but not necessarily complete recovery; unfavorable outcome was defined as score of ≤3, and favorable outcome was defined as a score of \>3)
One month, three and six months after injury or attack
Neurological function assessment
Modified Rankin scale score (0 = no symptoms; 1 = no significant disability; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = dead; favorable outcome was defined as score of 0-2, and unfavorable outcome was defined as score of 3-6)
One month, three and six months after injury or attack
Secondary Outcomes (1)
Neuroimaging evaluation
One week, two weeks after surgery; one month, three and six months after injury or attack
Study Arms (2)
Enhanced recovery after surgery
EXPERIMENTALThe technologies, processes and measures of enhanced recovery after surgery were applied.
Conventional therapy
ACTIVE COMPARATORConventional therapy were applied.
Interventions
The technologies, processes and measures of enhanced recovery after surgery focus on the following aspects: 1. Early assessment and treatment 2. Optimized anesthetic protocol 3. Reducing surgical stress 4. Multi-modal comprehensive monitoring 5. Comprehensive diagnosis and treatment in neurosurgical intensive care 6. Intensive early rehabilitation treatment
Eligibility Criteria
You may qualify if:
- Age 18-75 years old
- Patients with moderate or severe acute traumatic brain injury or cerebrovascular disease requiring neurosurgical intensive care treatment
- Hospitalization time ≥ 1 week
- The guardian is able to understand and actively cooperate in completing the project
- The guardian signs an informed consent form
You may not qualify if:
- Patients undergoing non-surgical treatment
- Patients diagnosed as brain death within the first 24 hours after admission to NICU
- Patients undergoing cardiopulmonary resuscitation, maintenance dialysis, end-stage tumors, and disseminated cancer
- Patients who withdraw treatment during hospitalization or are discharged automatically
- Patients who underwent unplanned secondary surgery during the research process
- Individuals who cannot be followed up during the research process
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai 6th People's Hospital
Shanghai, 200233, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hao Chen, M.D., Ph.D.
Shanghai 6th Peoples' Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Chief Physician, Graduate Supervisor
Study Record Dates
First Submitted
January 20, 2024
First Posted
February 5, 2024
Study Start
October 15, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
March 4, 2025
Record last verified: 2025-03