Meta-Analysis Accidental Hypothermia in Trauma | NCT04332237

Studies
Meta-Analysis Accidental Hypothermia in Trauma

NCT04332237

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Apr 2, 2020Actual

Enrollment

776,684Actual

Phase

Not provided

Conditions

Hypothermia
Trauma
Brain Injuries, Traumatic
Morality

Interventions

Not provided

Countries

Switzerland

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

Mar 2020

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

Aug 12, 2019Actual

Primary Completion Date

Jan 21, 2020Actual

Completion Date

Jan 21, 2020Actual

First Submitted Date

Mar 25, 2020

First Submission Date that Met QC Criteria

Mar 31, 2020

First Posted Date

Apr 2, 2020Actual

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

Mar 31, 2020

Last Update Posted Date

Apr 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is a systematic literature review and meta-analysis investigating the effect of accidental hypothermia on mortality in trauma patients overall and patients with TBI specifically.

Literature search will be performed using the Ovid Medline/PubMed database. Studies comparing the effect of hypothermia vs. normothermia at hospital admission on in-hospital mortality will be included in meta-analysis.

Detailed Description

Accidental hypothermia is a known predictor for worse outcomes in trauma patients, but has not been comprehensively assessed in meta-analysis so far. The aim of this systematic review and meta-analysis is to investigate the impact of accidental hypothermia on mortality in trauma patients overall and patients with traumatic brain injury (TBI) specifically.

Literature search will be conducted using the Ovid Medline/PubMed database. The search strategy will be based on the PICOS strategy.

Scientific articles reporting (1) accidental hypothermia in trauma patients overall or patients with TBI specifically, (2) body temperature and time of measurement, and (3) the impact of accidental hypothermia on outcomes will be included in the qualitative review.

Two meta-analyses will be performed including (1) trauma patients overall and (2) patients with TBI specifically. Studies reporting in-hospital mortality of hypothermic and normothermic trauma patients overall or patients with TBI specifically, based on the temperature measured at Emergency Department admission, will be included in meta-analysis. Meta-analysis will be performed using a Mantel-Haenszel random-effects model. The estimated effect size for mortality will be reported as odds ratio (OR) and 95% confidence interval (CI) for each study as well as for the overall cohort.

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

776,684Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypothermia group		Hypothermic trauma patients or hypothermic patients with traumatic brain injury specifically.
Normothermia group		Normothermic trauma patients or normothermic patients with traumatic brain injury specifically.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-hospital mortality	Death occurring during the hospital stay	From hospital admission to discharge, expected to be up to 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Original scientific articles
English language
Study in trauma patients
Reported body temperature and time of temperature measurement
Reported impact of accidental hypothermia on outcomes

Exclusion criteria:

Case reports
Systematic reviews
Articles on therapeutic hypothermia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Trauma patiens overall and patiens with traumatic brain injury specifically

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tobias Haltmeier, MD	Inselspital, Bern University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inselspital, Bern University Hospial		Bern		3010	Switzerland

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
D007035	Hypothermia
D014947	Wounds and Injuries
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001930	Brain Injuries

Browse Leaves

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Browse Branches

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