Histones and Free-plasma DNA After Cardiac Arrest
Histones and Free-plasma DNA in the Days Following the Cardiac Arrest
1 other identifier
observational
42
1 country
1
Brief Summary
To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones in cardiac arrest patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJune 2, 2017
June 1, 2017
8 months
March 30, 2016
June 1, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Plasma histones
The level of plasma histones
Approximate 24 hours after cardiac arrest
Free-plasma DNA
The level of total free-plasma DNA
Approximate 24 hours after cardiac arrest
Secondary Outcomes (2)
Plasma histones
Approximate 48 hours and 72 hours after cardiac arrest
Free-plasma DNA
Approximate 48 hours and 72 hours after cardiac arrest
Other Outcomes (2)
Simplified Acute Physiology Score (SAPS) score
Approximate 24 hours, 48 hours and 72 hours after cardiac arrest
Platelet count
Approximate 24 hours, 48 hours and 72 hours after cardiac arrest
Study Arms (1)
cardiac arrest patients
Patients who has suffered a cardiac arrest
Interventions
Eligibility Criteria
Cardiac arrest patients with a presumed cardiac origin, treated with targeted temperature management for 24 hours. For comparison; 20 healthy individuals were used.
You may qualify if:
- Out of hospital cardiac arrest of presumed cardiac cause
- Return of spontaneous circulation (ROSC)
- Glasgow Coma Score \< 8
- Age \> 18 years and \< 80 years
You may not qualify if:
- \>60 minutes from the circulatory collapse to ROSC
- Time interval \> 4 hours from cardiac arrest to initiation of targeted temperature management
- Terminal illness
- Coagulation disorder
- Unwitnessed asystolia
- Cerebral performance category 3-4 before the cardiac arrest
- Severe persistent cardiogenic shock
- Pregnancy
- Persistent cardiogenic shock (systolic blood pressure \< 80 despite inotropic treatment)
- New apoplexy or intracerebral hemorrhage
- Lack of consent from the relatives
- Lack of consent from the general practitioner
- Lack of consent from the patient if he/she wakes up and is relevant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital
Aarhus, Aarhus N, 8200, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2016
First Posted
April 11, 2016
Study Start
October 1, 2015
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
June 2, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share