Cardiac ArrestLAPTOPSNCT06992843
Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest
A study testing Goal-directed care bundle for neuroprotection in people with Cardiac Arrest and Post-cardiac Arrest Care, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The investigators designed LAPTOPS to determine the effectiveness of a goal-directed neuroprotection bundles of active management including body temperature,PaCO2,PaO2,position,Blood glucose ,blood sodium,Blood pressure and Lactate vs. usual care in adult post-cardiac arrest care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest, Post-cardiac Arrest Care
- What is being tested?
- Goal-directed care bundle for neuroprotection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,008 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2025to Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and < 80 years
- Patients of in-hospital or out-of-hospital cardiac arrest who have returned -spontaneous circulation (ROSC) after cardiopulmonary resuscitation and do not require CPR for more than 20 minutes;
- Patients who are unconscious after ROSC, defined as FOUR motor response score < 4 points or GSC ≤ 8 points;
- Family members or legal representatives signed informed consent.
Who cannot join
- Unwitnessed cardiac arrest, estimated time from cardiac arrest to start of CPR > 30 minutes;
- Time from cardiac arrest to ROSC > 60 minutes;
- Patients who woke up immediately after ROSC by CPR;
- End-stage diseases;
- Cardiac arrest considered to be caused by neurological diseases;
- The patient was in a vegetative state before cardiac arrest;
- The interval from the onset of cardiac arrest to enrollment is >72 hours .
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
Xiangya hospital，Central South University
Changsha, Hunan, 410000
Zheren Tan, Phd, 86+15616244605, tanzheren@126.com
About this study
Official title: A Multicenter, Prospective, Stepped Wedge Cluster Randomized Controlled Study on the Effect of Neuroprotection Bundles on the Improvement of Neurological Outcomes After Cardiopulmonary Resuscitation
The investigators designed LAPTOPS to determine the effectiveness of a goal-directed neuroprotection bundles of active management including body temperature,PaCO2,PaO2,position,Blood glucose ,blood sodium,Blood pressure and Lactate vs. usual care in adult post-cardiac arrest care.
LAPTOPS is a large-scale pragmatic clinical trial to provide reliable evidence over the effectiveness of a widely applicable goal-directed care bundle in acute phase of adult post-cardiac arrest care.
- Conditions
- Cardiac Arrest, Post-cardiac Arrest Care
- Being tested
- Goal-directed care bundle for neuroprotection, Usual Care
- Keywords
- post-cardiac arrest care, neuroprotection, cardiac arrest, Care Bundle, Clinical Trial, Stepped-wedge Cluster
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed care bundle for neuroprotectionOther
Reducing lactate (Lac) to <2 mmol/L within 24 hours.Maintaining systolic arterial pressure at 120-140 mmHg.
Elevating the head-of-bed to 30 degrees. Maintaining body temperature ≤37.7°C. Maintaining PaO₂ at 70-100 mmHg. Maintaining PaCO₂ at 35-45 mmHg. Maintaining blood glucose at 7.8-10.0 mmol/L. Maintaining serum sodium level at 140-150 mmol/L. If any management parameter falls outside the target range, immediate correction is required within 24 hours of enrollment and must be sustained for 72 hours. Given the dynamic nature of some targets (e.g., mean arterial pressure, body temperature), a degree of flexibility is permitted in achieving these goals. Patients are considered to have successfully implemented the neuroprotection bundle if the achievement rate of individual targets is ≥80% and all targets are met. The medications(antipyretics, vasopressor agents) is acceptable to achieve these targets.
Usual CareOther
Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.
| Study group | Role | What they receive |
|---|---|---|
| Goal-directed care bundle for neuroprotection | Other | Management policy to receive a goal-directed care bundle that involves the rapid correction (<24 hour) of physiological variables as soon as the abnormality is recognised and for the control to be maintained in patients for 72h or hospital discharge (or death, if sooner) Receives: Other: Goal-directed care bundle for neuroprotection |
| Usual care group | Other | Patients receive the usual management based on local guidelines and hospital's individual policy. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable neurological prognosis
Assessed using the CPC score, with a score of 1-2 being a favorable outcome.
Measured: 90 days post cardiac arrest
Secondary outcomes (12)
GCS score
GCS score
Measured: 7 days post cardiac arrest
CPC score
CPC score
Measured: 1 day (discharge date)
GCS score
GCS score
Measured: 1 day (discharge date)
Time to death
Number of days alive within 180 days from ROSC.
Measured: 180 days
the length of ICU stay
the length of ICU stay
Measured: The total length of IC-stay will be determined from the date of ICU admission until the patient is discharged from the Intensive Care Unit or the date of death from any cause, assessed up to 1 year after the first day of admission.
the length of hospital stay
the length of hospital stay
Measured: The total length of hospital-stay will be determined from the date of ICU admission until the patient is discharged from the hospital or the date of death from any cause assessed up to 1 year after the first day of admission.
the length of mechanical ventilation
the length of mechanical ventilation
Measured: Total ventilation time during ICU stay will be determined when the patient is discharged from the ICU or when the patient past away from any cause, assessed up to 1 year after the first day of admission.
the incidence of adverse event
The incidence of adverse effects during ICU treatment
Measured: From the date of ICU admission until the patient is discharged from the Intensive Care Unit or the date of death from any cause, assessed up to 1 year after the first day of admission.
in-hospital mortality
in-hospital mortality
Measured: The total length of hospital-stay will be determined from the date of ICU admission until the patient is discharged from the hospital or the date of death from any cause assessed up to 1 year after the first day of admission.
28-day mortality
28-day mortality
Measured: 28 days post cardiac arrest
Quality of life assessment
Health-related Quality of Life - EQ-5D (Index value)
Measured: 90 days post cardiac arrest
bundle compliance rate
referring to the proportion of patients whose management parameters are within the target ranges.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start22 Oct 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Stepped-wedge Cluster Randomised Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,008 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, icuzhanglina, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992843
- Sponsor's protocol ID
- 2024121757
- Acronym
- LAPTOPS
- Status last verified
- Jul 2025
- First submitted
- 6 May 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Stepped Wedge Cluster Randomized Controlled Study on the Effect of Neuroprotection Bundles on the Improvement of Neurological Outcomes After Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT06992843
- Acronym / sponsor ID
- LAPTOPS / 2024121757
- Conditions
- Cardiac Arrest, Post-cardiac Arrest Care
- Keywords
- post-cardiac arrest care, neuroprotection, cardiac arrest, Care Bundle, Clinical Trial, Stepped-wedge Cluster
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,008 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 May 2025 (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.
The investigators designed LAPTOPS to determine the effectiveness of a goal-directed neuroprotection bundles of active management including body temperature,PaCO2,PaO2,position,Blood glucose ,blood sodium,Blood pressure and Lactate vs. usual care in adult post-cardiac arrest care.
LAPTOPS is a large-scale pragmatic clinical trial to provide reliable evidence over the effectiveness of a widely applicable goal-directed care bundle in acute phase of adult post-cardiac arrest care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge Cluster Randomised Trial
| Arm | Type | Receives |
|---|---|---|
| Goal-directed care bundle for neuroprotection | Other | Other: Goal-directed care bundle for neuroprotectionManagement policy to receive a goal-directed care bundle that involves the rapid correction (<24 hour) of physiological variables as soon as the abnormality is recognised and for the control to be maintained in patients for 72h or hospital discharge (or death, if sooner) |
| Usual care group | Other | Other: Usual CarePatients receive the usual management based on local guidelines and hospital's individual policy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and < 80 years
- Patients of in-hospital or out-of-hospital cardiac arrest who have returned -spontaneous circulation (ROSC) after cardiopulmonary resuscitation and do not require CPR for more than 20 minutes;
- Patients who are unconscious after ROSC, defined as FOUR motor response score < 4 points or GSC ≤ 8 points;
- Family members or legal representatives signed informed consent.
Key exclusion criteria (7 listed)
- Unwitnessed cardiac arrest, estimated time from cardiac arrest to start of CPR > 30 minutes;
- Time from cardiac arrest to ROSC > 60 minutes;
- Patients who woke up immediately after ROSC by CPR;
- End-stage diseases;
- Cardiac arrest considered to be caused by neurological diseases;
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 |
|---|---|---|
| Goal-directed care bundle for neuroprotectionReducing lactate (Lac) to <2 mmol/L within 24 hours.Maintaining systolic arterial pressure at 120-140 mmHg. Elevating the head-of-bed to 30 degrees. Maintaining body temperature ≤37.7°C. Maintaining PaO₂ at 70-100 mmHg. Maintaining PaCO₂ at 35-45 mmHg. Maintaining blood glucose at 7.8-10.0 mmol/L. Maintaining serum sodium level at 140-150 mmol/L. If any management parameter falls outside the target range, immediate correction is required within 24 hours of enrollment and must be sustained for 72 hours. Given the dynamic nature of some targets (e.g., mean arterial pressure, body temperature), a degree of flexibility is permitted in achieving these goals. Patients are considered to have successfully implemented the neuroprotection bundle if the achievement rate of individual targets is ≥80% and all targets are met. The medications(antipyretics, vasopressor agents) is acceptable to achieve these targets. | Other | Goal-directed care bundle for neuroprotection |
| Usual CareUsual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team. | Other | Usual care group |
Primary outcome
Favorable neurological prognosis
Time frame: 90 days post cardiac arrest
Assessed using the CPC score, with a score of 1-2 being a favorable outcome.
12 secondary outcomes
GCS score
Time frame: 7 days post cardiac arrest
CPC score
Time frame: 1 day (discharge date)
GCS score
Time frame: 1 day (discharge date)
Time to death
Time frame: 180 days
the length of ICU stay
Time frame: The total length of IC-stay will be determined from the date of ICU admission until the patient is discharged from the Intensive Care Unit or the date of death from any cause, assessed up to 1 year after the first day of admission.
the length of hospital stay
Time frame: The total length of hospital-stay will be determined from the date of ICU admission until the patient is discharged from the hospital or the date of death from any cause assessed up to 1 year after the first day of admission.
the length of mechanical ventilation
Time frame: Total ventilation time during ICU stay will be determined when the patient is discharged from the ICU or when the patient past away from any cause, assessed up to 1 year after the first day of admission.
the incidence of adverse event
Time frame: From the date of ICU admission until the patient is discharged from the Intensive Care Unit or the date of death from any cause, assessed up to 1 year after the first day of admission.
in-hospital mortality
Time frame: The total length of hospital-stay will be determined from the date of ICU admission until the patient is discharged from the hospital or the date of death from any cause assessed up to 1 year after the first day of admission.
28-day mortality
Time frame: 28 days post cardiac arrest
Quality of life assessment
Time frame: 90 days post cardiac arrest
bundle compliance rate
Time frame: 72 hours
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 18 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-directed care bundle for neuroprotection in people with Cardiac Arrest and Post-cardiac Arrest Care, run by Xiangya Hospital of Central South University 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 4 inclusion and 7 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 18 Nov 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 Lina Zhang (86+15874875763, zln7095@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable neurological prognosis (time frame: 90 days post cardiac arrest). 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 18 Nov 2025.