臨床研究等提出・公開システム

Date of registration	June. 02, 2026
Last modified on	Aug. 12, 2026
Trial ID	jRCT1060260027

Scientific Title	Breakthrough Platform Trial for Post Cardiac Arrest Syndrome: A Cluster Randomized Trial (Breakthrough Platform Trial for Post Cardiac Arrest Syndrome: A Cluster Randomized Trial)
Public Title	BPT-PCAS Trial (BPT-PCAS Trial)

Contact for Scientific Queries	Name	Kawakita Kenya
	Affiliation	Kagawa University Hospital
	Address	1750-1,Ikenobe, Miki-cho, Kita-gun,Kagawa,761-0701,Japan
	Telephone	+81-87-891-2392
	E-mail	kawakita.kenya@kagawa-u.ac.jp
Contact for Public Queries	Name	Kataoka Yoko
	Affiliation	Kagawa University Hospital
	Address	1750-1,Ikenobe, Miki-cho, Kita-gun,Kagawa,761-0701,Japan
	Telephone	+81-87-891-5677
	E-mail	j-neuro@googlegroups.com

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 02, 2026
Target sample size		870
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients with return of spontaneous circulation (ROSC) after cardiac arrest who require intensive care management 2) Unconsciousness after ROSC (Glasgow Coma Scale motor score < 6) 3) 18 years or older
	Exclusion Criteria	1) Refusal of intensive care management 2) Extracorporeal cardiopulmonary resuscitation (ECPR) performed as cardiopulmonary resuscitation 3) Known or estimated pregnancy 4) Cardiac arrest (including suspected cases) due to intracerebral hemorrhage, subarachnoid hemorrhage, cerebral infarction, acute aortic dissection, or terminal cancer 5) Known chronic obstructive pulmonary disease with home oxygen therapy 6) Known cerebral performance category (CPC) of 3-4 or overall performance category (OPC) of 3-4 before cardiac arrest 7) Patients with a pre-existing do-not-attempt-resuscitation (DNAR) order at the time of cardiac arrest. 8) Anticipated early death 9) Consent not obtained or withdrawn by the participant or surrogate 10) Other reasons deemed inappropriate for participation by the investigator or subinvestigator
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Adult patients with cardiac arrest with persistent coma after ROSC and require intensive care
Intervention(s)		Head position (Adjustment of the bed backrest or whole-bed tilt) -Head elevation group (30-45 degree angle): head position maintained at 30-45 degree angle -Supine position group (0-10 degree angle): head position maintained at 0-10 bdegree angle Temperature control -Hypothermia group: Temperature maintained at 33-34 degree Celsius -Normothermia group: Temperature maintained at 36-37.5 degree Celsius
Health Condition(s) Keyword		adult cardiac arrest; adult; cardiac arrest; ROSC; coma; PCAS
Intervention(s) Keyword		Head position, Temperature control
Primary Outcome(s)		All-cause mortality at 90 days
Secondary Outcome(s)		-All-cause in-hospital mortality -Modified Rankin Scale (mRS) at hospital discharge, 30 days, and 90 days after admission

Primary Sponsor	None

Secondary Sponsor

Source of Monetary Support	BD External Funding Program
Secondary Sponsor	Not applicable

Name of Certified Review Board	The Research Ethics Committee of Kagawa University Faculty of Medicine.
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793 JAPAN, Kagawa
Telephone	+81-87-891-2011
E-Mail	kenkyushien-m@kagawa-u.ac.jp
Approval Status	Approval
Date of approval	May. 27, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Aug. 12, 2026	(this page)	Changes
2	Aug. 06, 2026	Detail	Changes
1	June. 02, 2026	Detail

List of change history