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Cardiac Arrest (CA)BPT-PCASNCT07769086

Breakthrough Platform Trial for PCAS

A study testing Head Positioning in people with Cardiac Arrest (CA) and Post Cardiac Arrest Syndrome, run by Kagawa University at 12 sites in Japan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this platform clinical trial is to evaluate whether specific post-cardiac arrest care strategies can improve neurological recovery and survival in adult patients who remain comatose after return of spontaneous circulation (ROSC) following cardiac arrest and require intensive care management. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Head Positioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
12 sitesJapan
Study dates
1 Sep 2026to 30 Jun 2031
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Master Platform Eligibility:
  • Adult patients aged 18 years or older
  • Return of spontaneous circulation after cardiac arrest
  • Persistent coma after return of spontaneous circulation (GCS motor score <6)
  • Requirement for intensive care management
  • Head Positioning Domain Eligibility:
Show all 12Show fewer
  • Non-traumatic out-of-hospital or in-hospital cardiac arrest
  • Systolic blood pressure ≥80 mmHg or mean arterial pressure ≥65 mmHg (fluid resuscitation and vasopressor use permitted; transient hypotension recoverable within 20-30 minutes is acceptable)
  • Temperature Control Domain Eligibility:
  • Initial non-shockable cardiac arrest rhythm
  • Systolic blood pressure ≥80 mmHg or mean arterial pressure ≥65 mmHg (fluid resuscitation and vasopressor use permitted; transient hypotension recoverable within 20-30 minutes is acceptable)
  • Ability to initiate temperature control therapy within 240 minutes after return of spontaneous circulation

Who cannot join

  • Master Platform Exclusion:
  • Refusal of intensive care management
  • Extracorporeal cardiopulmonary resuscitation (ECPR)
  • Pregnancy or possible pregnancy
  • Cardiac arrest due to intracranial hemorrhage, subarachnoid hemorrhage, cerebral infarction, acute aortic dissection, or terminal cancer (including suspected cases)
  • Severe chronic obstructive pulmonary disease requiring home oxygen therapy
Show all 25Show fewer
  • Poor pre-arrest neurological function (CPC 3-4) or poor overall functional status (OPC 3-4)
  • Pre-existing do-not-attempt-resuscitation (DNAR) order
  • Expected early death
  • Inability to obtain consent from a legally acceptable representative or the participant
  • Enrollment judged inappropriate by the investigator
  • Head Positioning Domain Exclusion:
  • Body temperature <30°C on hospital arrival
  • Refusal of consent for participation in the head positioning domain
  • Enrollment judged inappropriate by the investigator
  • Patients using Impella® (a percutaneous mechanical circulatory support catheter) at the time of ICU admission
  • Patients using an intra-aortic balloon pump (IABP) at the time of ICU admission
  • Patients for whom feedback-controlled device-based temperature management or fever prevention is not being performed and is not planned at the time of ICU admission
  • Temperature Control Domain Exclusion:
  • rCAST <4.5
  • rCAST ≥17.0
  • Traumatic cardiac arrest
  • Body temperature <30°C on hospital arrival
  • Refusal of consent for participation in the temperature control domain
  • Enrollment judged inappropriate by the investigator

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yasuhiro Kuroda, M.D, Ph.D contact

+81-87-891-2392

bpt-pcas@googlegroups.com

12 sites in 1 country

Japan12 sites
  • TMG Asaka Medical Center

    Asaka, Saitama, 3510023

    Yusuke Morohashi, +81-48-466-2055, yskmoro.yuyu0507@gmail.com

  • Nippon medical school hospital

    Bunkyō-Ku, Tokyo, 113-8603

    Toru Takiguchi, +81-3-3822-2131, toru-takiguchi@nms.ac.jp

  • Chiba Kaihin Municipal Hospital

    Chiba, Chiba, 2610012

    Yosuke Homma, +81-43-277-7711, jazz.dr.homma@gmail.com

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 7348551

    Mitsuaki Nishikimi, +81-82-257-5456, nishikim@hiroshima-u.ac.jp

  • Aso Iizuka Hospital

    Iizuka, Fukuoka, 8208505

    Daisuke Kawakami, +81-948-22-3800, dsk_kwkm_n9s@hotmail.co.jp

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0701

    Kenya Kawakita, +81-87-891-2382, kawakita.kenya@kagawa-u.ac.jp

  • Hyogo Emergency Medical Center

    Kobe, Hyōgo, 651-0073

    Takeshi Nishimura, +87-78-241-3131, t-nishimura@hemc.jp

  • Kyoto Katsura Hospital

    Kyoto, Kyoto, 6158256

    Taiga Sunada, +81-75-391-5811, sunada.taiga@gmail.com

  • Musashino Red Cross Hospital

    Musashino, Tokyo, 1800023

    Hidetaka Suzuki, +81-422-32-3111, h.suzuki@musashino.jrc.or.jp

  • Okayama University Hospital

    Okayama, Okayama-ken, 7008558

    Tetsuya Yumoto, +81-86-235-7427, tyumoto@cc.okayama-u.ac.jp

  • National Hospital Organization Sendai Medical Center

    Sendai, Miyagi, 9838520

    Yu Kawazoe, +81-22-293-1111, yu.kawazoe.b7@tohoku.ac.jp

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida-ku, Tokyo, 1308575

    Kazuhiro Sugiyama, +81-3-3633-6151, kazusugi0422@hotmail.com

Other trials in Japan

About this study

Official title: Breakthrough Platform Trial for Post Cardiac Arrest Syndrome

The goal of this platform clinical trial is to evaluate whether specific post-cardiac arrest care strategies can improve neurological recovery and survival in adult patients who remain comatose after return of spontaneous circulation (ROSC) following cardiac arrest and require intensive care management.

This multicenter cluster-randomized crossover platform trial (BPT-PCAS) evaluates post-cardiac arrest care strategies within a shared master protocol structure. Participating hospitals are randomized at the institutional level to predefined treatment strategies for fixed study periods and subsequently cross over to alternative strategies according to a predefined allocation schedule.

Read more

The platform is designed to accommodate multiple independent intervention domains, each evaluating a different post-cardiac arrest care strategy under shared eligibility criteria, infrastructure, data management systems, and follow-up procedures. Participants may be enrolled in one or more active intervention domains according to platform availability and eligibility.

Participants will receive the post-cardiac arrest care strategy assigned to their participating hospital during the study period while otherwise undergoing standard intensive care management according to local practice and study protocols.

Participants will be followed for neurological outcomes including modified Rankin Scale (mRS), mortality, and safety outcomes at hospital discharge, 30 days, and 90 days after hospital admission.

Read the detailed description

BPT-PCAS (Breakthrough Platform Trial for Post-Cardiac Arrest Syndrome) is a multicenter platform trial designed to evaluate whether early post-cardiac arrest care strategies can improve neurological recovery and survival in adult patients who remain comatose after return of spontaneous circulation (ROSC) following cardiac arrest and require intensive care management.

Despite advances in resuscitation and intensive care medicine, prognosis after post-cardiac arrest syndrome (PCAS) remains poor, particularly because of hypoxic-ischemic brain injury and systemic circulatory dysfunction. Many aspects of post-resuscitation intensive care management, including positioning strategies and targeted temperature management, are widely used in clinical practice but remain supported by limited high-quality randomized evidence, particularly during the ultra-early post-ROSC period.

BPT-PCAS is designed as a pragmatic multicenter cluster-randomized crossover platform trial conducted in Japan. Participating hospitals are randomized at the institutional level to predefined treatment strategies for fixed study periods. Hospitals subsequently cross over to alternative treatment strategies every 6 months according to a predefined allocation schedule. Randomization occurs at the hospital level rather than the individual patient level in order to facilitate immediate implementation of time-sensitive post-cardiac arrest interventions during emergency care.

The platform uses a master protocol structure with shared eligibility criteria, infrastructure, data management systems, and follow-up procedures across multiple intervention domains. Adult patients with persistent coma after ROSC who require intensive care are screened for eligibility under the master protocol. Individual domains may apply additional domain-specific inclusion and exclusion criteria.

The current platform includes multiple intervention domains evaluating different post-cardiac arrest care strategies.

One domain evaluates early head positioning strategies during intensive care management. This domain compares head elevation positioning (30°-45°) with near-supine positioning (0°-10°) initiated early after ICU admission in order to determine whether head positioning influences neurological recovery, mortality, and complications associated with cerebral perfusion, intracranial pressure, or respiratory management.

Another domain evaluates early targeted temperature management strategies in patients with non-shockable cardiac arrest rhythms. This domain compares early hypothermia (33-34°C) with normothermia (36-37.5°C) initiated as early as possible after ROSC in order to evaluate whether early temperature control improves neurological outcomes and survival.

Participants may simultaneously participate in more than one intervention domain when eligibility criteria are met. Aside from the assigned study interventions, all other intensive care management is performed according to local institutional practice and study protocols.

The primary and secondary outcomes differ according to each intervention domain and include neurological outcomes assessed using the modified Rankin Scale (mRS), mortality, and predefined safety outcomes. Follow-up assessments are performed during hospitalization and at 30 and 90 days after hospital admission.

Because eligible patients are critically ill and frequently incapable of providing prospective informed consent at the time of enrollment, this study permits deferred consent procedures in accordance with Japanese ethical guidelines for emergency research. Consent from legally acceptable representatives or patients themselves is obtained as soon as feasible after hospital admission whenever possible.

The study also includes predefined interim analyses and centralized data management using REDCap-based electronic data capture systems. Statistical analyses are performed using intention-to-treat principles with methods appropriate for cluster-randomized crossover trial designs.

Being tested
Head Positioning, Temperature Control
Keywords
platform trial, cluster randomized trial, head positioning, Temperature control
Medical subject headings
Heart Arrest, Post-Cardiac Arrest Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Head PositioningProcedure or surgery

    Institution-level assignment to predefined head positioning strategies during post-cardiac arrest intensive care management, including head elevation (30°-45°) or near-supine positioning (0°-10°).

  • Temperature ControlOther

    Institution-level assignment to predefined temperature control strategies during post-cardiac arrest intensive care management, including targeted hypothermia (33-34°C) or normothermia/fever prevention strategies (36-37.5°C).

Study groups in NCT07769086
Study groupRoleWhat they receive
Head Positioning Strategy (near-supine vs head elevation)ExperimentalParticipants receive institutionally assigned post-cardiac arrest head positioning strategies according to the cluster-randomized crossover platform protocol, including head elevation (30°-45°) or near-supine positioning (0°-10°).
Receives: Procedure: Head Positioning
Temperature Control Strategy (hypothermia vs normothermia)ExperimentalParticipants receive institutionally assigned post-cardiac arrest temperature control strategies according to the cluster-randomized crossover platform protocol, including targeted hypothermia (33-34°C) or normothermia/fever prevention strategies (36-37.5°C).
Receives: Other: Temperature Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the head positioning domain

    Comparison of Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 between institutionally assigned head positioning strategies in adult patients with post-cardiac arrest syndrome.

    Measured: 90 days after hospital admission

  2. Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the temperature control domain

    Comparison of neurological outcomes between institutionally assigned temperature control strategies in adult patients with post-cardiac arrest syndrome and non-shockable initial rhythms.

    Measured: 90 days after hospital admission

Secondary outcomes (4)
  1. mRS ≤3 on Day 30

    Comparison of neurological outcome (mRS ≤3) on Day 30 between institutionally assigned head positioning strategies in adult patients with post-cardiac arrest syndrome.

    Measured: 30 days after hospital admission

  2. mRS ≤3 on Day 30

    Comparison of neurological outcome (mRS ≤3) on Day 30 between institutionally assigned temperature control strategies in adult patients with post-cardiac arrest syndrome and non-shockable initial rhythms.

    Measured: 30 days after hospital admission

  3. All-cause mortality on Day 30 and Day 90

    Comparison of all-cause mortality on Day 30 and Day 90 between institutionally assigned head positioning strategies in adult patients with post-cardiac arrest syndrome.

    Measured: 30 days and 90 days after hospital admission

  4. All-cause mortality on Day 30 and Day 90

    Comparison of all-cause mortality on Day 30 and Day 90 between institutionally assigned temperature control strategies in adult patients with post-cardiac arrest syndrome and non-shockable initial rhythms.

    Measured: 30 days and 90 days after hospital admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Mar 2031 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

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
Crossover
Model description
This study is a multicenter cluster-randomized crossover platform trial evaluating post-cardiac arrest care strategies in adult patients with post-cardiac arrest syndrome. Participating hospitals are assigned to predefined intervention strategies at the institutional level and cross over between strategies at predefined intervals. The platform includes multiple intervention domains, including head positioning and temperature control strategies. Individual participants may be enrolled in one or more active intervention domains according to platform availability and eligibility. Enrollment reflects Domain 1 (head positioning, n=630); some patients are co-enrolled in Domain 2 (temperature control, n=240) based on rhythm eligibility
Masking
None (open label)
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07769086
Sponsor's protocol ID
bpt-pcas
Acronym
BPT-PCAS
Status last verified
Aug 2026
First submitted
12 Aug 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Head Positioning in people with Cardiac Arrest (CA) and Post Cardiac Arrest Syndrome, run by Kagawa University at 12 sites in Japan.

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 12 inclusion and 25 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. 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 Yasuhiro Kuroda, M.D, Ph.D (+81-87-891-2392, bpt-pcas@googlegroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the head positioning domain (time frame: 90 days after hospital admission). The study lists 2 primary outcomes in all. 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 17 Aug 2026.

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