Cardiac ArrestPANGEANCT02381977
Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment
An observational study of Cardiac Arrest and Stroke, run by University of Pittsburgh.
Trial summary
PANGEA is an international prospective point prevalence study to describe the epidemiology, interventions, and outcomes in children with acute critical brain disease. Read more about this study
- Who is it for?
- Ages 7 days to 17 years
- Conditions the study is for
- Cardiac Arrest, Stroke, Traumatic Brain Injury
- How many people
- 922 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Sep 2014
- 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 7 days to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Critically-ill children with acute neurologic injury
Who may be able to join
- Children aged 7 days to 17 years inclusively and admitted to an ICU (ICU can be classified as general, cardiac, trauma, etc).
- Children with acute or acute on chronic neurologic disease that occurred just prior to hospital admission or occurred during the hospital admission.
- Acute neurologic disease is secondary to TBI, stroke, brain mass, hydrocephalus, cardiac arrest, status epilepticus, CNS infection/inflammation, or spinal cord injury.
Who cannot join
- Children with acute perinatal neurologic disease.
- Children with isolated chronic brain injury and no acute neurologic disease.
About this study
PANGEA is an international prospective point prevalence study to describe the epidemiology, interventions, and outcomes in children with acute critical brain disease.
- Conditions
- Cardiac Arrest, Stroke, Traumatic Brain Injury, Brain Mass, Status Epilepticus, Spinal Cord Disease
- Being tested
- No intervention
- Medical subject headings
- Heart Arrest, Stroke, Brain Injuries, Traumatic, Status Epilepticus, Spinal Cord Diseases, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of acute brain insult
Measured: 4 days over a 1 year period
Secondary outcomes (1)
Mortality
Measured: Hospital discharge or 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 922 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Medical
- Responsible party
- Principal investigator, Ericka Fink, University of Pittsburgh
- Investigators
- Ericka Fink, MD, MS, Principal investigator, 4126925164
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381977
- Sponsor's protocol ID
- PANGEA
- Acronym
- PANGEA
- Status last verified
- Mar 2015
- First submitted
- 16 Feb 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment
- ClinicalTrials.gov ID
- NCT02381977
- Acronym / sponsor ID
- PANGEA / PANGEA
- Conditions
- Cardiac Arrest, Stroke, Traumatic Brain Injury, Brain Mass, Status Epilepticus, Spinal Cord Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 922 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Laerdal Medical
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Mar 2015 (estimated)
- 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.
PANGEA is an international prospective point prevalence study to describe the epidemiology, interventions, and outcomes in children with acute critical brain disease.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Critically-ill children with acute neurologic injury
Key inclusion criteria (3 listed)
- Children aged 7 days to 17 years inclusively and admitted to an ICU (ICU can be classified as general, cardiac, trauma, etc).
- Children with acute or acute on chronic neurologic disease that occurred just prior to hospital admission or occurred during the hospital admission.
- Acute neurologic disease is secondary to TBI, stroke, brain mass, hydrocephalus, cardiac arrest, status epilepticus, CNS infection/inflammation, or spinal cord injury.
Key exclusion criteria (2 listed)
- Children with acute perinatal neurologic disease.
- Children with isolated chronic brain injury and no acute neurologic disease.
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 |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Prevalence of acute brain insult
Time frame: 4 days over a 1 year period
1 secondary outcome
Mortality
Time frame: Hospital discharge or 3 months
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 6 Mar 2015.
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.
Ericka Fink, MD, MS principal investigator
4126925164
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Stroke, run by University of Pittsburgh.
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 3 inclusion and 2 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 6 Mar 2015. 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?
Prevalence of acute brain insult (time frame: 4 days over a 1 year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2015.