NCT02826057

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 7, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

June 16, 2016

Last Update Submit

July 4, 2016

Conditions

Out-of-Hospital Cardiac ArrestPost Cardiac Arrest Syndrome

Outcome Measures

Primary Outcomes (1)

  • MASP-2 concentration in plasma

    48 hours

Secondary Outcomes (27)

  • MASP-2 concentration in plasma

    24 hours, 48 hours and 72 hours

  • MASP-2 concentration in plasma

    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

  • +22 more secondary outcomes

Study Arms (2)

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)

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)

Other: Targeted temperature management (33 degree Celsius)

Interventions

Targeted temperature management (33 degree Celsius)OTHER
24 hour of targeted temperature management48 hour of targeted temperature management

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Out-of-Hospital Cardiac Arrest of presumed cardiac cause
  • Return of spontaneous circulation (ROSC)
  • Glasgow Coma Score \< 8
  • Age \> 18 years and \< 80 years

You may not qualify if:

  • \> 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Biomedicine, Aarhus University

Aarhus, 8000, Denmark

Location

Department of Anesthesiology and Intensive Care, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Department of Clinical Biochemistry, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestPost-Cardiac Arrest Syndrome

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesReperfusion InjuryVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

July 7, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

July 7, 2016

Record last verified: 2016-06

Locations

DK(3)