Out-of-Hospital Cardiac ArrestNCT02826057
The Complement Lectin Pathway After Cardiac Arrest
A study testing Targeted temperature management (33 degree Celsius) in people with Out-of-Hospital Cardiac Arrest and Post Cardiac Arrest Syndrome, run by University of Aarhus at 3 sites in Denmark.
Trial summary
This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24 hours or 48 hours of targeted temperature management. The overall aim is to evaluate the importance of plasma complement protein concentrations in patients resuscitated after out-of-hospital cardiac arrest and treated with 24… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest, Post Cardiac Arrest Syndrome
- What is being tested?
- Targeted temperature management (33 degree Celsius)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesDenmark
- Study dates
- Feb 2016to Jul 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
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 bloodpressure < 80 despite inotropic treatment)
- New apoplexy or cerebral hemorrhage
- Lack of consent from the relatives
- Lack of consent from the general practitioner
- Lack of consent from the patient
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Biomedicine, Aarhus University
Aarhus, 8000
Department of Anesthesiology and Intensive Care, Aarhus University Hospital
Aarhus, 8200
Department of Clinical Biochemistry, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest
This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24 hours or 48 hours of targeted temperature management.
The overall aim is to evaluate the importance of plasma complement protein concentrations in patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48 hours of targeted temperature management.
Read more
The specific aim is to evaluate:
- the concentration of plasma lectin pathway proteins the first, second and third day after cardiac arrest
- the relation between concentration of plasma lectin pathway proteins and mortality
- if prolonged targeted temperature management influences the concentration of plasma lectin pathway proteins
This study is a sub-study to the trial entitled: "Time-differentiated targeted temperature management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)"
The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin, M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.
- Being tested
- Targeted temperature management (33 degree Celsius)
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted temperature management (33 degree Celsius)Other
| Study group | Role | What they receive |
|---|---|---|
| 24 hour of targeted temperature management | Active comparator | Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius) Receives: Other: Targeted temperature management (33 degree Celsius) |
| 48 hour of targeted temperature management | Experimental | Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius) Receives: Other: Targeted temperature management (33 degree Celsius) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MASP-2 concentration in plasma
Measured: 48 hours
Secondary outcomes (27)
MASP-2 concentration in plasma
Measured: 24 hours, 48 hours and 72 hours
MASP-2 concentration in plasma
MASP-2 concentration in plasma compared with 30-day mortality
Measured: 24 hours, 48 hours, 72 hours
MASP-2 concentration in plasma
Measured: 24 hours to 72 hours
MASP-1 concentration in plasma
Measured: 24 hours, 48 hours and 72 hours
MASP-1 concentration in plasma
Measured: 24 hours to 72 hours
MASP-1 concentration in plasma
MASP-1 concentration in plasma compared with 30-day mortality
Measured: 24 hours, 48 hours, 72 hours
MASP-3 concentration in plasma
Measured: 24 hours, 48 hours and 72 hours
MASP-3 concentration in plasma
Measured: 24 hours to 72 hours
MASP-3 concentration in plasma
MASP-3 concentration in plasma compared with 30-day mortality
Measured: 24 hours, 48 hours, 72 hours
Mannan-Binding-Lectin concentration in plasma
Measured: 24 hours, 48 hours and 72 hours
Mannan-Binding-Lectin concentration in plasma
Measured: 24 hours to 72 hours
Mannan-Binding-Lectin concentration in plasma
Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality
Measured: 24 hours, 48 hours, 72 hours
MAp44 concentration in plasma
Measured: 24 hours, 48 hours and 72 hours
Map44 concentration in plasma
Measured: 24 hours to 72 hours
MAp44 concentration in plasma
MAp44 concentration in plasma compared with 30-day mortality
Measured: 24 hours, 48 hours, 72 hours
MAp19 concentration in plasma
Measured: 24 hours, 48 hours and 72 hours
MAp19 concentration in plasma
Measured: 24 hours to 72 hours
MAp19 concentration in plasma
MAp19 concentration in plasma compared with 30-day mortality
Measured: 24 hours, 48 hours, 72 hours
H-ficolin concentration in plasma
Measured: 24 hours, 48 hours and 72 hours
H-ficolin concentration in plasma
Measured: 24 hours to 72 hours
H-ficolin concentration in plasma
H-ficolin concentration in plasma compared with 30-day mortality
Measured: 24 hours, 48 hours, 72 hours
M-ficolin concentration in plasma
Measured: 24 hours, 48 hours and 72 hours
M-ficolin concentration in plasma
Measured: 24 hours to 72 hours
M-ficolin concentration in plasma
M-ficolin concentration in plasma compared with 30-day mortality
Measured: 24 hours, 48 hours, 72 hours
CL-L1 concentration in plasma
Measured: 24 hours, 48 hours and 72 hours
CL-L1 concentration in plasma
Measured: 24 hours to 72 hours
CL-L1 concentration in plasma
CL-L1 concentration in plasma compared with 30-day mortality
Measured: 24 hours, 48 hours, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-Hospital 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 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
- NCT02826057
- Sponsor's protocol ID
- 12345
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02826057
- Acronym / sponsor ID
- 12345
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 7 Jul 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.
This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24 hours or 48 hours of targeted temperature management.
The overall aim is to evaluate the importance of plasma complement protein concentrations in patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48 hours of targeted temperature management.
The specific aim is to evaluate:
- the concentration of plasma lectin pathway proteins the first, second and third day after cardiac arrest
- the relation between concentration of plasma lectin pathway proteins and mortality
- if prolonged targeted temperature management influences the concentration of plasma lectin pathway proteins
This study is a sub-study to the trial entitled: "Time-differentiated targeted temperature management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)"
The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin, M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 hour of targeted temperature management | Active comparator | Other: Targeted temperature management (33 degree Celsius)Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius) |
| 48 hour of targeted temperature management | Experimental | Other: Targeted temperature management (33 degree Celsius)Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Targeted temperature management (33 degree Celsius) | Other | 24 hour of targeted temperature management, 48 hour of targeted temperature management |
Primary outcome
MASP-2 concentration in plasma
Time frame: 48 hours
27 secondary outcomes
MASP-2 concentration in plasma
Time frame: 24 hours, 48 hours and 72 hours
MASP-2 concentration in plasma
Time frame: 24 hours, 48 hours, 72 hours
MASP-2 concentration in plasma
Time frame: 24 hours to 72 hours
MASP-1 concentration in plasma
Time frame: 24 hours, 48 hours and 72 hours
MASP-1 concentration in plasma
Time frame: 24 hours to 72 hours
MASP-1 concentration in plasma
Time frame: 24 hours, 48 hours, 72 hours
MASP-3 concentration in plasma
Time frame: 24 hours, 48 hours and 72 hours
MASP-3 concentration in plasma
Time frame: 24 hours to 72 hours
MASP-3 concentration in plasma
Time frame: 24 hours, 48 hours, 72 hours
Mannan-Binding-Lectin concentration in plasma
Time frame: 24 hours, 48 hours and 72 hours
Mannan-Binding-Lectin concentration in plasma
Time frame: 24 hours to 72 hours
Mannan-Binding-Lectin concentration in plasma
Time frame: 24 hours, 48 hours, 72 hours
MAp44 concentration in plasma
Time frame: 24 hours, 48 hours and 72 hours
Map44 concentration in plasma
Time frame: 24 hours to 72 hours
MAp44 concentration in plasma
Time frame: 24 hours, 48 hours, 72 hours
MAp19 concentration in plasma
Time frame: 24 hours, 48 hours and 72 hours
MAp19 concentration in plasma
Time frame: 24 hours to 72 hours
MAp19 concentration in plasma
Time frame: 24 hours, 48 hours, 72 hours
H-ficolin concentration in plasma
Time frame: 24 hours, 48 hours and 72 hours
H-ficolin concentration in plasma
Time frame: 24 hours to 72 hours
H-ficolin concentration in plasma
Time frame: 24 hours, 48 hours, 72 hours
M-ficolin concentration in plasma
Time frame: 24 hours, 48 hours and 72 hours
M-ficolin concentration in plasma
Time frame: 24 hours to 72 hours
M-ficolin concentration in plasma
Time frame: 24 hours, 48 hours, 72 hours
CL-L1 concentration in plasma
Time frame: 24 hours, 48 hours and 72 hours
CL-L1 concentration in plasma
Time frame: 24 hours to 72 hours
CL-L1 concentration in plasma
Time frame: 24 hours, 48 hours, 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted temperature management (33 degree Celsius) in people with Out-of-Hospital Cardiac Arrest and Post Cardiac Arrest Syndrome, run by University of Aarhus at 3 sites 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: status not confirmed, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
MASP-2 concentration in plasma (time frame: 48 hours). 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 7 Jul 2016.