The Complement Lectin Pathway After Cardiac Arrest

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.

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 Overview

• Status: Unknown
• Conditions: Out-of-Hospital Cardiac Arrest; Post Cardiac Arrest Syndrome
• Intervention / Treatment: Other: Targeted temperature management (33 degree Celsius)

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Department of Biomedicine, Aarhus University
  • Aarhus, Denmark, 8200
    • Department of Anesthesiology and Intensive Care, Aarhus University Hospital
  • Aarhus, Denmark, 8200
    • Department of Clinical Biochemistry, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: July 4, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Estimate): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 4, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Brain Injuries; Reperfusion Injury; Heart Arrest; Out-of-Hospital Cardiac Arrest; Post-Cardiac Arrest Syndrome
• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)