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Breakthrough Platform Trial for PCAS (BPT-PCAS)

2026년 8월 12일 업데이트: Yasuhiro Kuroda, Kagawa University

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.

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

630

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Yasuhiro Kuroda, M.D, Ph.D
전화번호: +81-87-891-2392
이메일: bpt-pcas@googlegroups.com

연구 장소

일본
- Chiba
  - Chiba, Chiba, 일본, 2610012
    - Chiba Kaihin Municipal Hospital
    - 연락하다:
      
      Yosuke Homma
      
      전화번호: +81-43-277-7711
      
      이메일: jazz.dr.homma@gmail.com
- Fukuoka
  - Iizuka, Fukuoka, 일본, 8208505
    - Aso Iizuka Hospital
    - 연락하다:
      
      Daisuke Kawakami
      
      전화번호: +81-948-22-3800
      
      이메일: dsk_kwkm_n9s@hotmail.co.jp
- Hiroshima
  - Hiroshima, Hiroshima, 일본, 7348551
    - Hiroshima University Hospital
    - 연락하다:
      
      Mitsuaki Nishikimi
      
      전화번호: +81-82-257-5456
      
      이메일: nishikim@hiroshima-u.ac.jp
- Hyōgo
  - Kobe, Hyōgo, 일본, 651-0073
    - Hyogo Emergency Medical Center
    - 연락하다:
      
      Takeshi Nishimura
      
      전화번호: +87-78-241-3131
      
      이메일: t-nishimura@hemc.jp
- Kagawa-ken
  - Kita-gun, Kagawa-ken, 일본, 761-0701
    - Kagawa University Hospital
    - 연락하다:
      
      Kenya Kawakita
      
      전화번호: +81-87-891-2382
      
      이메일: kawakita.kenya@kagawa-u.ac.jp
- Kyoto
  - Kyoto, Kyoto, 일본, 6158256
    - Kyoto Katsura Hospital
    - 연락하다:
      
      Taiga Sunada
      
      전화번호: +81-75-391-5811
      
      이메일: sunada.taiga@gmail.com
- Miyagi
  - Sendai, Miyagi, 일본, 9838520
    - National Hospital Organization Sendai Medical Center
    - 연락하다:
      
      Yu Kawazoe
      
      전화번호: +81-22-293-1111
      
      이메일: yu.kawazoe.b7@tohoku.ac.jp
- Okayama-ken
  - Okayama, Okayama-ken, 일본, 7008558
    - Okayama University Hospital
    - 연락하다:
      
      Tetsuya Yumoto
      
      전화번호: +81-86-235-7427
      
      이메일: tyumoto@cc.okayama-u.ac.jp
- Saitama
  - Asaka, Saitama, 일본, 3510023
    - TMG Asaka Medical Center
    - 연락하다:
      
      Yusuke Morohashi
      
      전화번호: +81-48-466-2055
      
      이메일: yskmoro.yuyu0507@gmail.com
- Tokyo
  - Bunkyō-Ku, Tokyo, 일본, 113-8603
    - Nippon Medical School Hospital
    - 연락하다:
      
      Toru Takiguchi
      
      전화번호: +81-3-3822-2131
      
      이메일: toru-takiguchi@nms.ac.jp
  - Musashino, Tokyo, 일본, 1800023
    - Musashino Red Cross Hospital
    - 연락하다:
      
      Hidetaka Suzuki
      
      전화번호: +81-422-32-3111
      
      이메일: h.suzuki@musashino.jrc.or.jp
  - Sumida-ku, Tokyo, 일본, 1308575
    - Tokyo Metropolitan Bokutoh Hospital
    - 연락하다:
      
      Kazuhiro Sugiyama
      
      전화번호: +81-3-3633-6151
      
      이메일: kazusugi0422@hotmail.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

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

Exclusion Criteria:

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
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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 크로스오버 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: Head Positioning Strategy (near-supine vs head elevation) 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°).	절차: Head Positioning 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°).
실험적: Temperature Control Strategy (hypothermia vs normothermia) 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).	다른: Temperature Control 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Favorable neurological outcome (modified Rankin Scale ≤3) on Day 90 in the head positioning domain 기간: 90 days after hospital admission	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 기간: 90 days after hospital admission	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

2차 결과 측정

결과 측정	측정값 설명	기간
mRS ≤3 on Day 30 기간: 30 days after hospital admission	Comparison of neurological outcome (mRS ≤3) on Day 30 between institutionally assigned head positioning strategies in adult patients with post-cardiac arrest syndrome.	30 days after hospital admission
mRS ≤3 on Day 30 기간: 30 days after hospital admission	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.	30 days after hospital admission
All-cause mortality on Day 30 and Day 90 기간: 30 days and 90 days after hospital admission	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.	30 days and 90 days after hospital admission
All-cause mortality on Day 30 and Day 90 기간: 30 days and 90 days after hospital admission	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.	30 days and 90 days after hospital admission

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Kagawa University

협력자

Becton, Dickinson and Company

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2031년 3월 31일

연구 완료 (추정된)

2031년 6월 30일

연구 등록 날짜

최초 제출

2026년 8월 12일

QC 기준을 충족하는 최초 제출

2026년 8월 12일

처음 게시됨 (실제)

2026년 8월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 12일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

bpt-pcas

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Breakthrough Platform Trial for PCAS (BPT-PCAS)

Breakthrough Platform Trial for Post Cardiac Arrest Syndrome

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (추정된)

단계

연락처 및 위치

연구 연락처

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

협력자

연구 기록 날짜

연구 주요 날짜

연구 시작 (추정된)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구