The Complement Lectin Pathway After Cardiac Arrest

The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02826057

Enrollment

Registered

2016-07-07

Start date

2016-02-29

Completion date

2017-07-31

Last updated

2016-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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 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.

Interventions

OTHERTargeted temperature management (33 degree Celsius)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
MASP-2 concentration in plasma	48 hours

Secondary

Measure	Time frame
MASP-1 concentration in plasma	24 hours, 48 hours and 72 hours
MASP-3 concentration in plasma	24 hours, 48 hours and 72 hours
Mannan-Binding-Lectin concentration in plasma	24 hours, 48 hours and 72 hours
MAp44 concentration in plasma	24 hours, 48 hours and 72 hours
MASP-2 concentration in plasma	24 hours, 48 hours and 72 hours
MAp19 concentration in plasma	24 hours, 48 hours and 72 hours
H-ficolin concentration in plasma	24 hours, 48 hours and 72 hours
M-ficolin concentration in plasma	24 hours, 48 hours and 72 hours
CL-L1 concentration in plasma	24 hours, 48 hours and 72 hours
Map44 concentration in plasma	24 hours to 72 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026