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Stepcare Extended Follow-up Substudy

Sponsor: Region Skane

NCT ID: NCT06207942

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Feed back controlled temperature device (device), High MAP (other), Deep sedation (other), Fever control without a device (other)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
Feed back controlled temperature device — device: If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius · High MAP — other: A mean arterial blood pressure (MAP) of \>85mmHg will be used. · Deep sedation — other: Deep sedation for at least 36 hours · Fever control without a device — other: Management of fever in the intensive care unit without a device · Low MAP — other: A mean arterial blood pressure (MAP) of \>65mmHG will be used. · Minimal sedation — other: A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures
Patient visit burden
Not specified by the sponsor

In plain English

This substudy follows people who took part in the STEPCARE trial after a cardiac arrest outside hospital and were successfully resuscitated. It also looks at their caregivers. The study focuses on brain injury caused by lack of oxygen, problems with memory and thinking, and the strain on caregivers.

Who can take part

  • You took part in the STEPCARE trial at a site taking part in the extended follow-up, survived, and agreed (consented) to take part
  • The original trial included people whose cardiac arrest happened outside hospital, was not caused by injury, and who stayed stable for at least 20 minutes without chest compressions
  • You were unconscious and could be treated in intensive care, and joined the trial within 4 hours of your blood flow returning
  • Caregivers: you live with the survivor, or have contact with them at least weekly (in person or by phone). Only one caregiver per survivor can take part

Who may not be able to

  • No one is excluded from this substudy beyond the original trial rules
  • The original trial excluded people on ECMO (a heart-lung support machine) before joining, people who were pregnant, people with suspected or confirmed bleeding in the brain, and people already in the STEPCARE trial

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
600
Started
2023-08-01
Last checked
2025-04

Plain English Summary

What is this study?

  • • Testing a new treatment for cardiac arrest with successful resuscitation
  • • NA - 600 participants
  • • To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with cardiac arrest with successful resuscitation

Where?

  • • Basildon - The Essex Cardiothoracic Centre
  • • Bristol - Bristol Royal Infirmary
  • • Cardiff - University hospital of Wales
  • • London - St Bartholomew's hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.

More detail

This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management. Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study. Participants will be followed up at 6 and 12 months. The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.

Cardiac Arrest With Successful ResuscitationHypoxia, BrainCognitive ImpairmentCaregiver Burden

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Who cannot take part

  • ✗on ECMO prior to randomization, pregnancy, suspected or confirmed intracranial hemorrhage, previously randomly assigned in...
See the full criteria
All OHCA participants randomized in the STEPCARE trial at the extended follow-up participating sites, who survive and provide consent, with no further inclusion or exclusion criteria. The inclusion and exclusion criteria for the STEPCARE trial are: * Inclusion criteria: out-of-hospital cardiac arrest of non-traumatic origin, minimum of 20 minutes without chest compressions (defined as stable return of spontaneous circulation. ROSC), unconsciousness (defined as not being able to obey verbal commands equal to a FOUR-score motor response of \<4, or being intubated and sedated because of agitation after sustained ROSC, eligible for intensive care without restrictions or limitation, inclusion within 4 hours (240 minutes) of ROSC (or 220 minutes of stable ROSC). * Exclusion criteria: on ECMO prior to randomization, pregnancy, suspected or confirmed intracranial hemorrhage, previously randomized in the STEPCARE trial. For caregivers, the eligibility will be that they live with, or have weekly or more frequent contact (in person or over the telephone) with the post OHCA survivor. Only one nominated caregiver per post OHCA survivor will be able to be included in the study. This would typically be the caregiver that would identify as the primary caregiver of the post OHCA survivor if needed, but may also be another close family member.

Where Is This Study? (4 UK sites)

The Essex Cardiothoracic Centre

Basildon, United Kingdom

Recruiting

Bristol Royal Infirmary

Bristol, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

University hospital of Wales

Cardiff, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elen de Lacy

PHW.Research@wales.nhs.uk02920 104468

St Bartholomew's hospital

London, United Kingdom

Recruiting

How to Get in Touch

Gisela Lilja, PhD

Sponsor contact

CONTACT

+4646176393 gisela.lilja@med.lu.se
Data sourced from ClinicalTrials.gov · Last verified: 2025-04