Histones and Free-plasma DNA After Cardiac Arrest | NCT02733146

Studies
Histones and Free-plasma DNA After Cardiac Arrest

NCT02733146

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 2, 2017Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Heart Arrest
Hypothermia
Post Cardiac Arrest Syndrome

Interventions

cardiac arrest

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Mar 30, 2016

First Submission Date that Met QC Criteria

Apr 4, 2016

First Posted Date

Apr 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2017

Last Update Posted Date

Jun 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cardiac arrest patients		Patients who has suffered a cardiac arrest	Other: cardiac arrest

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiac arrest	Other		cardiac arrest patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Plasma histones	The level of plasma histones	Approximate 48 hours and 72 hours after cardiac arrest
Free-plasma DNA	The level of total free plasma DNA

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital		Aarhus	Aarhus N	8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D007035	Hypothermia
D000080942	Post-Cardiac Arrest Syndrome

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001832	Body Temperature Changes
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006324	Heart Arrest, Induced

Ancestor Terms

ID	Term
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided