HypothermiaNCT04332237
Meta-Analysis Accidental Hypothermia in Trauma
An observational study of Hypothermia and Trauma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypothermia, Trauma, Brain Injuries, Traumatic
- How many people
- 776,684 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Aug 2019to 21 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Trauma patiens overall and patiens with traumatic brain injury specifically
Who may be able to join
- Original scientific articles
- English language
- Study in trauma patients
- Reported body temperature and time of temperature measurement
- Reported impact of accidental hypothermia on outcomes
Who cannot join
- Case reports
- Systematic reviews
- Articles on therapeutic hypothermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Accidental Hypothermia on Mortality in Trauma Patients Overall and Patients With Traumatic Brain Injury Specifically: A Systematic Review and Meta-Analysis
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.
Read the 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.
- Conditions
- Hypothermia, Trauma, Brain Injuries, Traumatic, Morality
- Medical subject headings
- Hypothermia, Wounds and Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death occurring during the hospital stay
Measured: From hospital admission to discharge, expected to be up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start12 Aug 2019
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 776,684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Haltmeier, MD, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332237
- Sponsor's protocol ID
- SRMA hypothermia trauma
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Accidental Hypothermia on Mortality in Trauma Patients Overall and Patients With Traumatic Brain Injury Specifically: A Systematic Review and Meta-Analysis
- ClinicalTrials.gov ID
- NCT04332237
- Acronym / sponsor ID
- SRMA hypothermia trauma
- Conditions
- Hypothermia, Trauma, Brain Injuries, Traumatic, Morality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 776,684 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Trauma patiens overall and patiens with traumatic brain injury specifically
Key inclusion criteria (5 listed)
- Original scientific articles
- English language
- Study in trauma patients
- Reported body temperature and time of temperature measurement
- Reported impact of accidental hypothermia on outcomes
Key exclusion criteria (3 listed)
- Case reports
- Systematic reviews
- Articles on therapeutic hypothermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: From hospital admission to discharge, expected to be up to 4 weeks
Death occurring during the hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: No
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Haltmeier, MD principal investigator
Inselspital, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia and Trauma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: From hospital admission to discharge, expected to be up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.