Massive Blood LossNCT04399902
Study to Actively Warm Trauma Patients
A study testing Thermal Blanket in people with Massive Blood Loss and Hypothermia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This study evaluates the feasibility of using thermal blankets to actively warm massively bleeding trauma patients at Sunnybrook Health Sciences Centre. It is hypothesized that either full thermal blankets or half thermal blankets will be a feasible intervention to implement for the care of massively bleeding trauma… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Massive Blood Loss, Hypothermia
- What is being tested?
- Thermal Blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2020to 1 Apr 2021
- Phase
- Interventional
- 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
Who may be able to join
- Any trauma patient requiring activation of the massive hemorrhage protocol (life- threatening bleeding situation requiring mobilization of blood bank, laboratory and clinical resources, and anticipated need for at least 4 units of red blood cells immediately and component therapy) during the hours when research staff are available. Normothermic (core body temperature between 36˚C or greater) will also be included, as core body temperature drops once resuscitation is initiated.
- Hypothermic patients (temperature ≤ 35˚C) to whom MHP is NOT activated, when Dr. Luis da Luz/trauma fellow is on call as Trauma Team Leader will also be included.
Who cannot join
- Patients known to be pregnant
- Patients who die in the trauma bay
- Patients excluded at the discretion of the TTL based on use of the blanket not appearing feasible given the sustained injuries, multiple procedures being conducted in the trauma, or patients who seem to have unsurvivable injuries.
- Patients admitted during study off-hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STudy to ActivelY WARM Trauma Patients (STAY WARM): A Feasibility Pilot Evaluation
This study evaluates the feasibility of using thermal blankets to actively warm massively bleeding trauma patients at Sunnybrook Health Sciences Centre. It is hypothesized that either full thermal blankets or half thermal blankets will be a feasible intervention to implement for the care of massively bleeding trauma patients.
Read the detailed description
Hypothermia (core body temperature of <36˚C), is a strong risk factor for mortality and poor outcomes in trauma patients due to its negative hemostatic, cardiovascular, respiratory, and renal effects. Current evidence has reported that massively bleeding hypothermic trauma patients have higher odds of mortality in the first 24 hours of hospital admission, increased length of stay, and increased need for transfusion. Standard hospital blankets are used to passively warm patients through resuscitation and treatment until arrival to the ICU. Interventions such as active heating through thermal blankets should be considered to prevent and treat hypothermia upon arrival of patients than standard warmed hospital blankets to prevent deleterious outcomes in this population.
- Conditions
- Massive Blood Loss, Hypothermia
- Being tested
- Thermal Blanket
- Keywords
- warming blankets, trauma, bleeding
- Medical subject headings
- Hypothermia, Wounds and Injuries, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal BlanketDevice
Ready-Heat 6-Panel Blanket (Military style, manufactured by Techtrade LLC). The 6-panel military-style blanket (86cm x 152 cm, 1.13kg) warms to 40˚C in approximately 15-20 minutes and maintains this temperature for 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| Study blanket | Experimental | Two standard warmed hospital blankets will be placed on top of the patient and the study blanket on top of the standard warmed blankets, covering as much of the patient as possible, at the discretion of the care team. At all times, clinicians should ensure that the study blanket does not touch the patient's bare skin.The blanket will remain on the patient through their path of care, and removed from the patient at arrival to the ICU/final phase of care, or if the patient temperature exceeds 38˚C at any point. Receives: Device: Thermal Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Was the blanket applied to the patient?
Binary indication of whether or not the blanket is applied to the patient
Measured: Through study completion, an average of 24 hours
Were patient temperatures recorded?
At least 2 temperature recordings (1 in the trauma bay and 1 in the next phase of care - CT scanner suite, angioembolozation suite, emergency department [ED], or operating room), or preferentially, at the final phase of care usually the ICU or ED
Measured: Through study completion, an average of 24 hours
Did the blanket remain on the patient?
Binary indication of whether or not the blanket is kept on the patient in each phase of care until arrival to ICU (1, 2, 3, 4, 5, and 6-hours post initial application of the blanket)
Measured: Through study completion, an average of 24 hours
Secondary outcomes (4)
Was the blanket placed directly on the patients skin?
Number of times blanket is placed directly on the skin
Measured: Through study completion, an average of 24 hours
Cold Discomfort Questionnaire
Assess cold discomfort of the patient during resuscitation (min value=0 [warm], max value=10 [unbearably cold])
Measured: Up to 2 weeks
Did the patients temperature exceed 38 degrees Celsius?
Binary outcome of whether patient temperature exceeded 38 degrees Celsius throughout phases of care
Measured: Through study completion, an average of 24 hours
Did the patient experience any redness and/or burns?
Number of times redness and/or burns are reported by the patient and/or treating clinician
Measured: Through study completion, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start5 Oct 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Massive Blood LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Teodoro da Luz, Sunnybrook Health Sciences Centre
- Investigators
- Luis T da Luz, MD, MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399902
- Sponsor's protocol ID
- STAY WARM Trial
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Publications
Strauss R, Kron A, Callum J, Armali C, Modi D, Notario L, D'Empaire PP, Tillmann BW, Pannell D, Tien H, Nathens A, Beckett A, da Luz LT. STudy to ActivelY WARM trauma patients (STAY WARM): a pilot study assessing feasibility of self-warming blankets in patients requiring a massive hemorrhage protocol activation. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2289-2294. doi: 10.1007/s00068-024-02612-w. Epub 2024 Aug 7.
PubMed 39112757
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STudy to ActivelY WARM Trauma Patients (STAY WARM): A Feasibility Pilot Evaluation
- ClinicalTrials.gov ID
- NCT04399902
- Acronym / sponsor ID
- STAY WARM Trial
- Conditions
- Massive Blood Loss, Hypothermia
- Keywords
- warming blankets, trauma, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 22 May 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 study evaluates the feasibility of using thermal blankets to actively warm massively bleeding trauma patients at Sunnybrook Health Sciences Centre. It is hypothesized that either full thermal blankets or half thermal blankets will be a feasible intervention to implement for the care of massively bleeding trauma patients.
Detailed description
Hypothermia (core body temperature of <36˚C), is a strong risk factor for mortality and poor outcomes in trauma patients due to its negative hemostatic, cardiovascular, respiratory, and renal effects. Current evidence has reported that massively bleeding hypothermic trauma patients have higher odds of mortality in the first 24 hours of hospital admission, increased length of stay, and increased need for transfusion. Standard hospital blankets are used to passively warm patients through resuscitation and treatment until arrival to the ICU. Interventions such as active heating through thermal blankets should be considered to prevent and treat hypothermia upon arrival of patients than standard warmed hospital blankets to prevent deleterious outcomes in this population.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study blanket | Experimental | Device: Thermal BlanketTwo standard warmed hospital blankets will be placed on top of the patient and the study blanket on top of the standard warmed blankets, covering as much of the patient as possible, at the discretion of the care team. At all times, clinicians should ensure that the study blanket does not touch the patient's bare skin.The blanket will remain on the patient through their path of care, and removed from the patient at arrival to the ICU/final phase of care, or if the patient temperature exceeds 38˚C at any point. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Any trauma patient requiring activation of the massive hemorrhage protocol (life- threatening bleeding situation requiring mobilization of blood bank, laboratory and clinical resources, and anticipated need for at least 4 units of red blood cells immediately and component therapy) during the hours when research staff are available. Normothermic (core body temperature between 36˚C or greater) will also be included, as core body temperature drops once resuscitation is initiated.
- Hypothermic patients (temperature ≤ 35˚C) to whom MHP is NOT activated, when Dr. Luis da Luz/trauma fellow is on call as Trauma Team Leader will also be included.
Key exclusion criteria (4 listed)
- Patients known to be pregnant
- Patients who die in the trauma bay
- Patients excluded at the discretion of the TTL based on use of the blanket not appearing feasible given the sustained injuries, multiple procedures being conducted in the trauma, or patients who seem to have unsurvivable injuries.
- Patients admitted during study off-hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal BlanketReady-Heat 6-Panel Blanket (Military style, manufactured by Techtrade LLC). The 6-panel military-style blanket (86cm x 152 cm, 1.13kg) warms to 40˚C in approximately 15-20 minutes and maintains this temperature for 10 hours. | Device | Study blanket |
Primary outcome
Was the blanket applied to the patient?
Time frame: Through study completion, an average of 24 hours
Binary indication of whether or not the blanket is applied to the patient
Were patient temperatures recorded?
Time frame: Through study completion, an average of 24 hours
At least 2 temperature recordings (1 in the trauma bay and 1 in the next phase of care - CT scanner suite, angioembolozation suite, emergency department [ED], or operating room), or preferentially, at the final phase of care usually the ICU or ED
Did the blanket remain on the patient?
Time frame: Through study completion, an average of 24 hours
Binary indication of whether or not the blanket is kept on the patient in each phase of care until arrival to ICU (1, 2, 3, 4, 5, and 6-hours post initial application of the blanket)
4 secondary outcomes
Was the blanket placed directly on the patients skin?
Time frame: Through study completion, an average of 24 hours
Cold Discomfort Questionnaire
Time frame: Up to 2 weeks
Did the patients temperature exceed 38 degrees Celsius?
Time frame: Through study completion, an average of 24 hours
Did the patient experience any redness and/or burns?
Time frame: Through study completion, an average of 24 hours
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 19 Apr 2021.
- Derived from this study: PubMed 39112757Strauss R, Kron A, Callum J, Armali C, Modi D, Notario L, D'Empaire PP, Tillmann BW, Pannell D, Tien H, Nathens A, Beckett A, da Luz LT. STudy to ActivelY WARM trauma patients (STAY WARM): a pilot study assessing feasibility of self-warming blankets in patients requiring a massive hemorrhage protocol activation. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2289-2294. doi: 10.1007/s00068-024-02612-w. Epub 2024 Aug 7.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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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.
Luis T da Luz, MD, MSc principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Blanket in people with Massive Blood Loss and Hypothermia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 2 inclusion and 4 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 19 Apr 2021. 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 Canada. 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?
Was the blanket applied to the patient? (time frame: Through study completion, an average of 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399902, which also lists 1 linked publication.
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 19 Apr 2021.