Neurocritical CareNCT06241482
Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care
A study testing Enhanced recovery after surgery and Conventional therapy in people with Neurocritical Care and Traumatic Brain Injury, run by Shanghai 6th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neurocritical Care, Traumatic Brain Injury, Cerebrovascular Disease
- What is being tested?
- Enhanced recovery after surgery and Conventional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai 6th People's Hospital
Shanghai, 200233
Hao Chen, M.D., Ph.D.
About this study
Official title: A Randomized Controlled Clinical Study on Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care Patients
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.
- Conditions
- Neurocritical Care, Traumatic Brain Injury, Cerebrovascular Disease, Moderate or Severe Coma
- Being tested
- Enhanced recovery after surgery, Conventional therapy
- Keywords
- Neurocritical Care, Traumatic Brain Injury, Cerebrovascular Disease
- Medical subject headings
- Brain Injuries, Traumatic, Cerebrovascular Disorders, Lymphoma, Follicular, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgeryProcedure or surgery
The technologies, processes and measures of enhanced recovery after surgery focus on the following aspects:
- Early assessment and treatment
- Optimized anesthetic protocol
- Reducing surgical stress
- Multi-modal comprehensive monitoring
- Comprehensive diagnosis and treatment in neurosurgical intensive care
- Intensive early rehabilitation treatment
Conventional therapyProcedure or surgery
Conventional therapy in neurocritical care.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced recovery after surgery | Experimental | The technologies, processes and measures of enhanced recovery after surgery were applied. Receives: Procedure: Enhanced recovery after surgery |
| Conventional therapy | Active comparator | Conventional therapy were applied. Receives: Procedure: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: One month, three and six months after injury or attack
Secondary outcomes (1)
Neuroimaging evaluation
Computer tomography or magnetic resonance imaging
Measured: One week, two weeks after surgery; one month, three and six months after injury or attack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Oct 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocritical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Hao Chen, MD, PhD, Shanghai 6th People's Hospital
- Investigators
- Hao Chen, M.D., Ph.D., Study director, Shanghai 6th Peoples' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241482
- Sponsor's protocol ID
- 2024-179
- Status last verified
- Mar 2025
- First submitted
- 20 Jan 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Study on Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care Patients
- ClinicalTrials.gov ID
- NCT06241482
- Acronym / sponsor ID
- 2024-179
- Conditions
- Neurocritical Care, Traumatic Brain Injury, Cerebrovascular Disease, Moderate or Severe Coma
- Keywords
- Neurocritical Care, Traumatic Brain Injury, Cerebrovascular Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced recovery after surgery | Experimental | Procedure: Enhanced recovery after surgeryThe technologies, processes and measures of enhanced recovery after surgery were applied. |
| Conventional therapy | Active comparator | Procedure: Conventional therapyConventional therapy were applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery after surgeryThe 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 | Procedure or surgery | Enhanced recovery after surgery |
| Conventional therapyConventional therapy in neurocritical care. | Procedure or surgery | Conventional therapy |
Primary outcome
Clinical prognosis
Time frame: One month, three and six months after injury or attack
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)
Neurological function assessment
Time frame: One month, three and six months after injury or attack
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)
1 secondary outcome
Neuroimaging evaluation
Time frame: One week, two weeks after surgery; one month, three and six months after injury or attack
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hao Chen, M.D., Ph.D. study director
Shanghai 6th Peoples' Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery after surgery and Conventional therapy in people with Neurocritical Care and Traumatic Brain Injury, run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Chen, M.D., Ph.D. (8602164369181 ext. 8405, hao.chen@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical prognosis (time frame: One month, three and six months after injury or attack). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.