Cardiac ArrestCRASSNCT03571113
Cardiac Arrest Survival Score (CRASS)
An observational study of Cardiac Arrest, run by German Resuscitation Registry.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Survival / not survival
- How many people
- 8,603 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2016
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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%.
Who cannot join
- incomplete dataset
- age less than 18 years
- unknown initial ECG
- unknown age
- unknown neurological status on hospital discharge
- 1,371 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.
About this study
Official title: Cardiac Arrest Survival Score (CRASS) - a Tool to Predict Good Neurological Outcome After Out of Hospital Cardiac Arrest
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.
Read the detailed description
This study is a retrospective analysis of 8,603 prospectively documented OHCA patients between 01.01.2010 and 31.12.2016 within the German Resuscitation Registry (GRR),4 attended by EMS. The GRR represents currently approximately 160 emergency medical systems who record data on out-of-hospital resuscitation attempts throughout Germany, thus encompassing approximately 30 million citizens (total population of Germany counts 85 million).
The German Resuscitation Registry for out-of-hospital cardiac arrest is divided into two different datasets:
- The 'Preclinical care' dataset originated from the Utstein-style template aiming at documentation of pre-hospital logistic issues, presumed aetiology, resuscitation therapy and patient's initial outcome including 118 variables.12
- The 'Postresuscitation care' dataset is aimed at documentation of in-hospital post-resuscitation efforts. The participating hospitals can choose between a basic version which includes the use of coronary angiography, temperature management and the status at hospital discharged and an extended version. This includes 156 variables and inquires especially the status at admission, initial blood gas analysis, temperature management, coronary angiography and survival at 24h after cardiac arrest, 30 days and at hospital discharge exactly.12 Participation in the registry is voluntary. The participating emergency medical services and hospitals submit their data anonymously into a central database via a web-based application. Multiple plausibility checks have been implemented into this application in order to improve data quality. The registry is organised and funded by the German Society of Anaesthesiology and Intensive Care Medicine (DGAI).
- Conditions
- Cardiac Arrest
- Being tested
- Survival / not survival
- Keywords
- cardiac arrest, OHCA survival score, predicting survival, German Resuscitation Registry
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survival / not survivalOther
Outcome with good neurological status vs. bad neurological status at hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| Development | The study population was divided into two parts by random: development dataset (5,775) and validation dataset (1,457) Receives: Other: Survival / not survival | |
| Validation | The study population was divided into two parts by random: development dataset (5,775) and validation dataset (1,457) Receives: Other: Survival / not survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
good neurological outcome
CPC 1 and 2 or mRS 0-2
Measured: 30 days after OHCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Jan 2010
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,603 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- German Resuscitation Registry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan-Thorsten Gräsner, MD, Study director, Institute for Emergency Medicine, Department of Anesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571113
- Sponsor's protocol ID
- 2018-1
- Acronym
- CRASS
- Status last verified
- Feb 2020
- First submitted
- 16 Jun 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21515626
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Arrest Survival Score (CRASS) - a Tool to Predict Good Neurological Outcome After Out of Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03571113
- Acronym / sponsor ID
- CRASS / 2018-1
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, OHCA survival score, predicting survival, German Resuscitation Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,603 participants (actual)
- Lead sponsor
- German Resuscitation RegistryUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a retrospective analysis of 8,603 prospectively documented OHCA patients between 01.01.2010 and 31.12.2016 within the German Resuscitation Registry (GRR),4 attended by EMS. The GRR represents currently approximately 160 emergency medical systems who record data on out-of-hospital resuscitation attempts throughout Germany, thus encompassing approximately 30 million citizens (total population of Germany counts 85 million).
The German Resuscitation Registry for out-of-hospital cardiac arrest is divided into two different datasets:
- The 'Preclinical care' dataset originated from the Utstein-style template aiming at documentation of pre-hospital logistic issues, presumed aetiology, resuscitation therapy and patient's initial outcome including 118 variables.12
- The 'Postresuscitation care' dataset is aimed at documentation of in-hospital post-resuscitation efforts. The participating hospitals can choose between a basic version which includes the use of coronary angiography, temperature management and the status at hospital discharged and an extended version. This includes 156 variables and inquires especially the status at admission, initial blood gas analysis, temperature management, coronary angiography and survival at 24h after cardiac arrest, 30 days and at hospital discharge exactly.12 Participation in the registry is voluntary. The participating emergency medical services and hospitals submit their data anonymously into a central database via a web-based application. Multiple plausibility checks have been implemented into this application in order to improve data quality. The registry is organised and funded by the German Society of Anaesthesiology and Intensive Care Medicine (DGAI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development | – | Other: Survival / not survivalThe study population was divided into two parts by random: development dataset (5,775) and validation dataset (1,457) |
| Validation | – | Other: Survival / not survivalThe study population was divided into two parts by random: development dataset (5,775) and validation dataset (1,457) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (6 listed)
- incomplete dataset
- age less than 18 years
- unknown initial ECG
- unknown age
- unknown neurological status on hospital discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survival / not survivalOutcome with good neurological status vs. bad neurological status at hospital discharge | Other | Development, Validation |
Primary outcome
good neurological outcome
Time frame: 30 days after OHCA
CPC 1 and 2 or mRS 0-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 21515626Grasner 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.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Thorsten Gräsner, MD study director
Institute for Emergency Medicine, Department of Anesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by German Resuscitation Registry.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
good neurological outcome (time frame: 30 days after OHCA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03571113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.