Breakthrough Platform Trial for PCAS

NCT07769086 | Not Yet Recruiting DMC

• 1 other identifier: bpt-pcas
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 12

Brief 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. 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. 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.

Conditions

Cardiac Arrest (CA); Post Cardiac Arrest Syndrome

Keywords

platform trial; cluster randomized trial; head positioning; Temperature control

Outcome Measures

Primary Outcomes (2)

• 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.

  90 days after hospital admission

• 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.

  90 days after hospital admission

Secondary Outcomes (4)

• mRS ≤3 on Day 30

  30 days after hospital admission

• mRS ≤3 on Day 30

  30 days after hospital admission

• All-cause mortality on Day 30 and Day 90

  30 days and 90 days after hospital admission

• All-cause mortality on Day 30 and Day 90

  30 days and 90 days after hospital admission

Study Arms (2)

Head Positioning Strategy (near-supine vs head elevation)

EXPERIMENTAL

Participants 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°).

Procedure: Head Positioning

Temperature Control Strategy (hypothermia vs normothermia)

EXPERIMENTAL

Participants 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).

Other: Temperature Control

Interventions

Head Positioning PROCEDURE

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°).

Head Positioning Strategy (near-supine vs head elevation)

Temperature Control OTHER

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).

Temperature Control Strategy (hypothermia vs normothermia)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Kagawa University: lead
• Becton, Dickinson and Company: collaborator

Study Sites (12)

Chiba Kaihin Municipal Hospital

Chiba, Chiba, 2610012, Japan

Location

Aso Iizuka Hospital

Iizuka, Fukuoka, 8208505, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, 7348551, Japan

Location

Hyogo Emergency Medical Center

Kobe, Hyōgo, 651-0073, Japan

Location

Kagawa University Hospital

Kita-gun, Kagawa-ken, 761-0701, Japan

Location

Kyoto Katsura Hospital

Kyoto, Kyoto, 6158256, Japan

Location

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, 9838520, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, 7008558, Japan

Location

TMG Asaka Medical Center

Asaka, Saitama, 3510023, Japan

Location

Nippon medical school hospital

Bunkyō-Ku, Tokyo, 113-8603, Japan

Location

Musashino Red Cross Hospital

Musashino, Tokyo, 1800023, Japan

Location

Tokyo Metropolitan Bokutoh Hospital

Sumida-ku, Tokyo, 1308575, Japan

Location

MeSH Terms

Conditions

Heart Arrest; Post-Cardiac Arrest Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yasuhiro Kuroda, M.D, Ph.D

CONTACT

+81-87-891-2392; bpt-pcas@googlegroups.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the institutional post-cardiac arrest care interventions, participating hospitals and treating clinicians are not blinded to assigned treatment strategies. The study is conducted using an open-label cluster-randomized crossover design.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: August 17, 2026

Record last verified: 2026-08

Locations

JP (12)