The Complement Lectin Pathway After Cardiac Arrest

Study Overview
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Brief Summary
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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.

Official Title
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The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest

Conditions
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Out-of-Hospital Cardiac Arrest, Post Cardiac Arrest Syndrome

Intervention / Treatment
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* Other: Targeted temperature management (33 degree Celsius)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-of-Hospital Cardiac Arrest of presumed cardiac cause Return of spontaneous circulation (ROSC) Glasgow Coma Score < 8 Age > 18 years and < 80 years Exclusion Criteria: > 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 24 hour of targeted temperature management<br>Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius) | Other: Targeted temperature management (33 degree Celsius)<br> <br> |
| Experimental: 48 hour of targeted temperature management<br>Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius) | Other: Targeted temperature management (33 degree Celsius)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MASP-2 concentration in plasma |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MASP-2 concentration in plasma |  | 24 hours, 48 hours and 72 hours | 
| MASP-2 concentration in plasma | MASP-2 concentration in plasma compared with 30-day mortality | 24 hours, 48 hours, 72 hours | 
| MASP-2 concentration in plasma |  | 24 hours to 72 hours | 
| MASP-1 concentration in plasma |  | 24 hours, 48 hours and 72 hours | 
| MASP-1 concentration in plasma |  | 24 hours to 72 hours | 
| MASP-1 concentration in plasma | MASP-1 concentration in plasma compared with 30-day mortality | 24 hours, 48 hours, 72 hours | 
| MASP-3 concentration in plasma |  | 24 hours, 48 hours and 72 hours | 
| MASP-3 concentration in plasma |  | 24 hours to 72 hours | 
| MASP-3 concentration in plasma | MASP-3 concentration in plasma compared with 30-day mortality | 24 hours, 48 hours, 72 hours | 
| Mannan-Binding-Lectin concentration in plasma |  | 24 hours, 48 hours and 72 hours | 
| Mannan-Binding-Lectin concentration in plasma |  | 24 hours to 72 hours | 
| Mannan-Binding-Lectin concentration in plasma | Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality | 24 hours, 48 hours, 72 hours | 
| MAp44 concentration in plasma |  | 24 hours, 48 hours and 72 hours | 
| Map44 concentration in plasma |  | 24 hours to 72 hours | 
| MAp44 concentration in plasma | MAp44 concentration in plasma compared with 30-day mortality | 24 hours, 48 hours, 72 hours | 
| MAp19 concentration in plasma |  | 24 hours, 48 hours and 72 hours | 
| MAp19 concentration in plasma |  | 24 hours to 72 hours | 
| MAp19 concentration in plasma | MAp19 concentration in plasma compared with 30-day mortality | 24 hours, 48 hours, 72 hours | 
| H-ficolin concentration in plasma |  | 24 hours, 48 hours and 72 hours | 
| H-ficolin concentration in plasma |  | 24 hours to 72 hours | 
| H-ficolin concentration in plasma | H-ficolin concentration in plasma compared with 30-day mortality | 24 hours, 48 hours, 72 hours | 
| M-ficolin concentration in plasma |  | 24 hours, 48 hours and 72 hours | 
| M-ficolin concentration in plasma |  | 24 hours to 72 hours | 
| M-ficolin concentration in plasma | M-ficolin concentration in plasma compared with 30-day mortality | 24 hours, 48 hours, 72 hours | 
| CL-L1 concentration in plasma |  | 24 hours, 48 hours and 72 hours | 
| CL-L1 concentration in plasma |  | 24 hours to 72 hours | 
| CL-L1 concentration in plasma | CL-L1 concentration in plasma compared with 30-day mortality | 24 hours, 48 hours, 72 hours |