NCT03571113

Brief Summary

Survival following cardiopulmonary resuscitation (CPR) from out-of-hospital cardiac arrest (OHCA) depends on numerous prehospital and in-hospital variables and interventions. The aim of this study was to develop a score to predict the resuscitation outcome after OHCA at hospital discharge. All patients suffered OHCA between 01.01.2010 and 31.12.2016 with ROSC or ongoing CPR at hospital admission in Emergency Medical Service (EMS) systems with good quality in documentation in the German Resuscitation Registry (GRR) were included. The study population was divided into development dataset (5,775) and validation dataset (1,457) by random. Binary logistic regression analysis was used to derive the score. Hospital discharge with good neurological function (CPC 1-2 or mRS 0-2) was used as dependent variable, and various combination of potential predictor variables were used to create the model.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,603

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

7 years

First QC Date

June 16, 2018

Last Update Submit

February 4, 2020

Conditions

Keywords

cardiac arrest, OHCA survival score, predicting survival, German Resuscitation Registry

Outcome Measures

Primary Outcomes (1)

  • good neurological outcome

    CPC 1 and 2 or mRS 0-2

    30 days after OHCA

Study Arms (2)

Development

The study population was divided into two parts by random: development dataset (5,775) and validation dataset (1,457)

Other: Survival / not survival

Validation

The study population was divided into two parts by random: development dataset (5,775) and validation dataset (1,457)

Other: Survival / not survival

Interventions

Outcome with good neurological status vs. bad neurological status at hospital discharge

DevelopmentValidation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between 01.01.2010 and 31.12.2016 the 'Preclinical care' dataset contained 8,603 out-of-hospital CA patients with return of spontaneous circulation (ROSC) or ongoing CPR at hospital admission in EMS systems with good documentation quality.

You may qualify if:

  • OHCA between 01.01.2010 and 31.12.2016
  • ROSC or ongoing CPR on hopsital admission
  • high quality documentation with more than 75% documentation of post resuscitation care in hospital
  • Patients cases documented in German Resuscitation Registry
  • Between 01.01.2010 and 31.12.2016 the 'Preclinical care' dataset contained 8,603 out-of-hospital CA patients with return of spontaneous circulation (ROSC) or ongoing CPR at hospital admission in EMS systems with good documentation quality. Good quality of documentation was defined by documented post-resuscitation care in more than 75%.

You may not qualify if:

  • incomplete dataset
  • age less than 18 years
  • unknown initial ECG
  • unknown age
  • unknown neurological status on hospital discharge
  • ,371 patients were excluded from further analysis because of incomplete data in terms of age, neurological status at hospital discharge, unknown initial EKG or age \< 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Grasner JT, Meybohm P, Lefering R, Wnent J, Bahr J, Messelken M, Jantzen T, Franz R, Scholz J, Schleppers A, Bottiger BW, Bein B, Fischer M; German Resuscitation Registry Study Group. ROSC after cardiac arrest--the RACA score to predict outcome after out-of-hospital cardiac arrest. Eur Heart J. 2011 Jul;32(13):1649-56. doi: 10.1093/eurheartj/ehr107. Epub 2011 Apr 22.

    PMID: 21515626BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jan-Thorsten Gräsner, MD

    Institute for Emergency Medicine, Department of Anesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2018

First Posted

June 27, 2018

Study Start

January 1, 2010

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share