Value of CT-based Autopsy Compared With Conventional Auto... | NCT01040520

Studies
Value of CT-based Autopsy Compared With Conventional Autopsy in ICU Patients

NCT01040520

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Last Update Posted

May 29, 2015Estimated

Enrollment

284Actual

Phase

Not provided

Conditions

Autopsy

Interventions

Not provided

Countries

Not provided

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

May 2015

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

Jan 2010

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Dec 28, 2009

First Submission Date that Met QC Criteria

Dec 28, 2009

First Posted Date

Dec 29, 2009Estimated

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

May 28, 2015

Last Update Posted Date

May 29, 2015Estimated

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

Description Module

Brief Summary

The aim of the study is to compare findings generated by CT-based autopsy (Virtopsy) with conventional autopsy and clinical diagnoses. Therefore all patients dying while receiving treatment in the Department of Intensive Care Medicine will be undergo virtopsy and, if relatives give informed consent conventional autopsy.

Detailed Description

The aim of the study is to compare findings generated by computertomography-based autopsy (Virtopsy) with conventional autopsy and clinical diagnoses. Therefore all patients dying while receiving treatment in the Department of Intensive Care Medicine will be undergo virtopsy and, if relatives give informed consent conventional autopsy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

284Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients dying in the Department of Intensive Care Medicine while receiving treatment during the study period

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients who die while receiving treatment in the Department of Intensive Care Medicine

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22250143	Derived	Wichmann D, Obbelode F, Vogel H, Hoepker WW, Nierhaus A, Braune S, Sauter G, Pueschel K, Kluge S. Virtual autopsy as an alternative to traditional medical autopsy in the intensive care unit: a prospective cohort study. Ann Intern Med. 2012 Jan 17;156(2):123-30. doi: 10.7326/0003-4819-156-2-201201170-00008.