The Complement Lectin Pathway After Cardiac Arrest

Out-of-Hospital Cardiac Arrest Clinical Trial

Official title:

The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02826057
• Other study ID #: 12345
• Status: Active, not recruiting
• Phase: N/A
• First received: June 16, 2016
• Last updated: July 4, 2016
• Start date: February 2016
• Est. completion date: July 2017

Study information

• Verified date: June 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Post Cardiac Arrest Syndrome

Intervention

Other:
• Targeted temperature management (33 degree Celsius)

Locations

Country	Name	City	State
Denmark	Department of Anesthesiology and Intensive Care, Aarhus University Hospital	Aarhus
Denmark	Department of Biomedicine, Aarhus University	Aarhus
Denmark	Department of Clinical Biochemistry, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MASP-2 concentration in plasma		48 hours	No
Secondary	MASP-2 concentration in plasma		24 hours, 48 hours and 72 hours	No
Secondary	MASP-2 concentration in plasma	MASP-2 concentration in plasma compared with 30-day mortality	24 hours, 48 hours, 72 hours	No
Secondary	MASP-2 concentration in plasma		24 hours to 72 hours	No
Secondary	MASP-1 concentration in plasma		24 hours, 48 hours and 72 hours	No
Secondary	MASP-1 concentration in plasma		24 hours to 72 hours	No
Secondary	MASP-1 concentration in plasma	MASP-1 concentration in plasma compared with 30-day mortality	24 hours, 48 hours, 72 hours	No
Secondary	MASP-3 concentration in plasma		24 hours, 48 hours and 72 hours	No
Secondary	MASP-3 concentration in plasma		24 hours to 72 hours	No
Secondary	MASP-3 concentration in plasma	MASP-3 concentration in plasma compared with 30-day mortality	24 hours, 48 hours, 72 hours	No
Secondary	Mannan-Binding-Lectin concentration in plasma		24 hours, 48 hours and 72 hours	No
Secondary	Mannan-Binding-Lectin concentration in plasma		24 hours to 72 hours	No
Secondary	Mannan-Binding-Lectin concentration in plasma	Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality	24 hours, 48 hours, 72 hours	No
Secondary	MAp44 concentration in plasma		24 hours, 48 hours and 72 hours	No
Secondary	Map44 concentration in plasma		24 hours to 72 hours	No
Secondary	MAp44 concentration in plasma	MAp44 concentration in plasma compared with 30-day mortality	24 hours, 48 hours, 72 hours	No
Secondary	MAp19 concentration in plasma		24 hours, 48 hours and 72 hours	No
Secondary	MAp19 concentration in plasma		24 hours to 72 hours	No
Secondary	MAp19 concentration in plasma	MAp19 concentration in plasma compared with 30-day mortality	24 hours, 48 hours, 72 hours	No
Secondary	H-ficolin concentration in plasma		24 hours, 48 hours and 72 hours	No
Secondary	H-ficolin concentration in plasma		24 hours to 72 hours	No
Secondary	H-ficolin concentration in plasma	H-ficolin concentration in plasma compared with 30-day mortality	24 hours, 48 hours, 72 hours	No
Secondary	M-ficolin concentration in plasma		24 hours, 48 hours and 72 hours	No
Secondary	M-ficolin concentration in plasma		24 hours to 72 hours	No
Secondary	M-ficolin concentration in plasma	M-ficolin concentration in plasma compared with 30-day mortality	24 hours, 48 hours, 72 hours	No
Secondary	CL-L1 concentration in plasma		24 hours, 48 hours and 72 hours	No
Secondary	CL-L1 concentration in plasma		24 hours to 72 hours	No
Secondary	CL-L1 concentration in plasma	CL-L1 concentration in plasma compared with 30-day mortality	24 hours, 48 hours, 72 hours	No