Goal-directed neuroprotection bundle for adults after cardiac arrest

A Multicenter, Prospective, Stepped Wedge Cluster Randomized Controlled Study on the Effect of Neuroprotection Bundles on the Improvement of Neurological Outcomes After Cardiopulmonary Resuscitation

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1008 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06992843 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Changsha, Hunan

• Xiangya hospital，Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Lina Zhang

Conditions Cardiac Arrest; Post-cardiac Arrest Care; post-cardiac arrest care; neuroprotection; cardiac arrest; Care Bundle; Clinical Trial; Stepped-wedge Cluster