Heart ArrestNCT02733146
Histones and Free-plasma DNA After Cardiac Arrest
An observational study of Heart Arrest and Hypothermia, run by University of Aarhus at 1 site in Denmark.
Trial summary
To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones in cardiac arrest patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Arrest, Hypothermia, Post Cardiac Arrest Syndrome
- What is being tested?
- cardiac arrest
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Sep 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiac arrest patients with a presumed cardiac origin, treated with targeted temperature management for 24 hours. For comparison; 20 healthy individuals were used.
Who may be able to join
- Out of hospital cardiac arrest of presumed cardiac cause
- Return of spontaneous circulation (ROSC)
- Glasgow Coma Score < 8
- Age > 18 years and < 80 years
Who cannot join
- >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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital
Aarhus, Aarhus N, 8200
About this study
Official title: Histones and Free-plasma DNA in the Days Following the Cardiac Arrest
To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones in cardiac arrest patients.
- Conditions
- Heart Arrest, Hypothermia, Post Cardiac Arrest Syndrome
- Being tested
- cardiac arrest
- Medical subject headings
- Heart Arrest, Hypothermia, Post-Cardiac Arrest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac arrestOther
| Study group | Role | What they receive |
|---|---|---|
| cardiac arrest patients | Patients who has suffered a cardiac arrest Receives: Other: cardiac arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma histones
The level of plasma histones
Measured: Approximate 24 hours after cardiac arrest
Free-plasma DNA
The level of total free-plasma DNA
Measured: Approximate 24 hours after cardiac arrest
Secondary outcomes (2)
Plasma histones
The level of plasma histones
Measured: Approximate 48 hours and 72 hours after cardiac arrest
Free-plasma DNA
The level of total free plasma DNA
Measured: Approximate 48 hours and 72 hours after cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733146
- Sponsor's protocol ID
- AU170878
- Status last verified
- Jun 2017
- First submitted
- 30 Mar 2016
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histones and Free-plasma DNA in the Days Following the Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02733146
- Acronym / sponsor ID
- AU170878
- Conditions
- Heart Arrest, Hypothermia, Post Cardiac Arrest Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Apr 2016 (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.
To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones in cardiac arrest patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac arrest patients | – | Other: cardiac arrestPatients who has suffered a cardiac arrest |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac arrest patients with a presumed cardiac origin, treated with targeted temperature management for 24 hours. For comparison; 20 healthy individuals were used.
Key inclusion criteria (4 listed)
- Out of hospital cardiac arrest of presumed cardiac cause
- Return of spontaneous circulation (ROSC)
- Glasgow Coma Score < 8
- Age > 18 years and < 80 years
Key exclusion criteria (13 listed)
- >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
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 |
|---|---|---|
| cardiac arrest | Other | cardiac arrest patients |
Primary outcome
Plasma histones
Time frame: Approximate 24 hours after cardiac arrest
The level of plasma histones
Free-plasma DNA
Time frame: Approximate 24 hours after cardiac arrest
The level of total free-plasma DNA
2 secondary outcomes
Plasma histones
Time frame: Approximate 48 hours and 72 hours after cardiac arrest
Free-plasma DNA
Time frame: Approximate 48 hours and 72 hours after cardiac arrest
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 2 Jun 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest and Hypothermia, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 13 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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Plasma histones (time frame: Approximate 24 hours after cardiac arrest). The study lists 2 primary outcomes in all. 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 2 Jun 2017.