The Validation and Development of Termination-of-Resuscit... | NCT05545176

Studies
The Validation and Development of Termination-of-Resuscitation (TOR) Rules in OHCA Patients in Asia Countries

NCT05545176

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Feb 25, 2026Actual

Enrollment

140,000Estimated

Phase

Not provided

Conditions

Out-Of-Hospital Cardiac Arrest

Interventions

termination of resuscitation rules

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2007Actual

Primary Completion Date

Jun 1, 2032Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Sep 14, 2022

First Submission Date that Met QC Criteria

Sep 14, 2022

First Posted Date

Sep 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2026

Last Update Posted Date

Feb 25, 2026Actual

Name	Class
Singapore Clinical Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objectives/Hypotheses

Prehospital termination-of-resuscitation (TOR) rules were developed in North American and European sites. Whether they remained valid in different geographic, ethnic, and cultural background areas is still under debate.
Differences in characteristics of out-of-hospital cardiac arrests (OHCAs) and configurations of emergency medical service (EMS) between the Western and Asian countries, including relatively lower rate of presenting shockable rhythm (i.e. ventricular fibrillation / ventricular tachycardia; VF/VT), lower rates of bystander CPR, less advanced life support (ALS) implementation, and less public access defibrillators, might create potential threats to the prediction accuracy of TOR rules.
We aim to conduct a study to validate the performance of ever published TOR rules in Asian OHCA population, including non-traumatic, traumatic, and pediatric OHCA patients. Furthermore, assess the possible variables that may impact the performance of TOR rules.
We also aim to develop new TOR rules based on PAROS registry for Asia population, focusing on non-traumatic, traumatic, and pediatric OHCA patients, respectively.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
out of hospital cardiac arrest patients in Asia countries			Other: termination of resuscitation rules

Interventions

Name	Type	Description	Arm Group Labels	Other Names
termination of resuscitation rules	Other	Use retrospective data to analyze the accuracy termination of resuscitation rules and further develope a termination of resuscitation rule.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival to hospital discharge	survival to 30-day hospitalisation	survival to 30-day hospitalisation

Secondary Outcomes

Measure	Description	Time Frame
Cerebral Performance Categories Scale (CPC)	CPC Scale 1~5, minimum value: 1; maximum value:5; lower score means greater outcome	CPC within 30-day hospitalisation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

out of hospital cardiac arrest (OHCA) patients

Exclusion Criteria:

age <18 years
non-EMS transport to the emergency department
obvious signs of death (e.g. decapitation, rigor mortis, lividity, and decapitation) or having do-not-resuscitate (DNR) orders
missing data despite meeting the inclusion criteria.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population included adults, OHCA patients since1 January 2007, identified from the PAROS registry. The PAROS data encompass 13 countries. The exclusion criteria include: (1) age <18 years, (2) non-EMS transport to the emergency department, (3) obvious signs of death (e.g. decapitation, rigor mortis, lividity, and decapitation) or having do-not-resuscitate (DNR) orders, and (4) missing data despite meeting the inclusion criteria.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shu-Hsien Hsu, MPH	Contact			pedroe929@gmail.com

Overall Officials

Name	Affiliation	Role
Shu-Hsien Hsu, MPH	National Taiwan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University	Recruiting	Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Clinical Study Report (CSR)

Time Frame

30 years

Access Criteria

PAROS study members

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058687	Out-of-Hospital Cardiac Arrest

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided