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NCT Number: NCT06992843

Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Post-cardiac Arrest Care

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiangya hospital，Central South University

Changsha, Hunan, 410000, China

Location status: Recruiting

Location contact

Zheren Tan, Phd

CONTACT

[email protected]

86+15616244605

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Goal-directed care bundle for neuroprotection

Other

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 Care

Other

Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.

Primary outcomes

  1. 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.

Secondary outcomes

  1. GCS score

    Time frame: 7 days post cardiac arrest

    GCS score

  2. CPC score

    Time frame: 1 day (discharge date)

    CPC score

  3. GCS score

    Time frame: 1 day (discharge date)

    GCS score

  4. Time to death

    Time frame: 180 days

    Number of days alive within 180 days from ROSC.

  5. 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 ICU stay

  6. 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 hospital stay

  7. 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 length of mechanical ventilation

  8. 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.

    The incidence of adverse effects during ICU treatment

  9. 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.

    in-hospital mortality

  10. 28-day mortality

    Time frame: 28 days post cardiac arrest

    28-day mortality

  11. Quality of life assessment

    Time frame: 90 days post cardiac arrest

    Health-related Quality of Life - EQ-5D (Index value)

  12. bundle compliance rate

    Time frame: 72 hours

    referring to the proportion of patients whose management parameters are within the target ranges.

Study contacts

Contact information is provided by the study sponsor or research team.

Lina Zhang

CONTACT

[email protected]

86+15874875763

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study 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

Acronym: LAPTOPS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 28, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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