Goal-directed neuroprotection bundle for adults after cardiac arrest
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
Run by Xiangya Hospital of Central South University · NCT06992843 · Data updated 2026-11-12
This trial will test whether a goal-directed bundle of treatments (temperature, breathing gases, position, blood pressure, glucose, sodium and lactate control) helps adults who are unconscious after return of circulation from cardiac arrest recover their brain function better than usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1008 (estimated) |
| Sponsor | Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | October 22, 2025 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT06992843 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 79 who achieve return of spontaneous circulation after cardiac arrest, remain unconscious (FOUR motor score <4 or GCS ≤8), and can be enrolled within the trial's acute time windows are ideal candidates.
✕Probably not a fit
Patients who regained consciousness immediately after ROSC, had unwitnessed or prolonged arrests, had ROSC beyond the allowed time windows, had end-stage disease, or had cardiac arrest from a primary neurologic cause are unlikely to benefit from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
LAPTOPS is a pragmatic interventional trial that randomizes adult patients who remain unconscious after return of spontaneous circulation following in- or out-of-hospital cardiac arrest to either a goal-directed neuroprotection care bundle or usual care. The bundle targets body temperature, PaCO2, PaO2, patient positioning, blood glucose, sodium, blood pressure and lactate levels during the acute post-arrest phase. The trial enrolls adults aged 18–79 who achieve ROSC within prespecified time windows and whose surrogates provide consent. Clinical and neurological recovery outcomes are compared between groups to determine whether a standardized bundle improves recovery in routine care settings.
Why it matters
Potential benefit: If successful, the bundle could improve neurological recovery and survival after cardiac arrest by standardizing acute neuroprotective management.
How similar studies have gone: Individual elements such as targeted temperature management and blood pressure/oxygen control have shown mixed benefits in prior work, but combining them into a standardized goal-directed bundle is less well tested and remains novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 .
Where it's running
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Xiangya hospital,Central South University
Changsha, Hunan, China Recruiting
Study contacts
- Study coordinator: Lina Zhang
- Email: zln7095@163.com
- Phone: 86+15874875763
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.