NCT04332237

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
776,684

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 25, 2020

Last Update Submit

March 31, 2020

Conditions

HypothermiaTraumaBrain Injuries, TraumaticMorality

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    Death occurring during the hospital stay

    From hospital admission to discharge, expected to be up to 4 weeks

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trauma patiens overall and patiens with traumatic brain injury specifically

You may qualify if:

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

You may not qualify if:

  • Case reports
  • Systematic reviews
  • Articles on therapeutic hypothermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Bern University Hospial

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

HypothermiaWounds and InjuriesBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Study Officials

  • Tobias Haltmeier, MD

    Inselspital, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 25, 2020

First Posted

April 2, 2020

Study Start

August 12, 2019

Primary Completion

January 21, 2020

Study Completion

January 21, 2020

Last Updated

April 2, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)