NCT02733146

Brief Summary

To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones in cardiac arrest patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

March 30, 2016

Last Update Submit

June 1, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Plasma histones

    The level of plasma histones

    Approximate 24 hours after cardiac arrest

  • Free-plasma DNA

    The level of total free-plasma DNA

    Approximate 24 hours after cardiac arrest

Secondary Outcomes (2)

  • Plasma histones

    Approximate 48 hours and 72 hours after cardiac arrest

  • Free-plasma DNA

    Approximate 48 hours and 72 hours after cardiac arrest

Other Outcomes (2)

  • Simplified Acute Physiology Score (SAPS) score

    Approximate 24 hours, 48 hours and 72 hours after cardiac arrest

  • Platelet count

    Approximate 24 hours, 48 hours and 72 hours after cardiac arrest

Study Arms (1)

cardiac arrest patients

Patients who has suffered a cardiac arrest

Other: cardiac arrest

Interventions

cardiac arrest patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac arrest patients with a presumed cardiac origin, treated with targeted temperature management for 24 hours. For comparison; 20 healthy individuals were used.

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 blood pressure \< 80 despite inotropic treatment)
  • New apoplexy or intracerebral hemorrhage
  • Lack of consent from the relatives
  • Lack of consent from the general practitioner
  • Lack of consent from the patient if he/she wakes up and is relevant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Heart ArrestHypothermiaPost-Cardiac Arrest Syndrome

Interventions

Heart Arrest, Induced

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesReperfusion InjuryVascular DiseasesPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Cardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 11, 2016

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

June 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations