TraumaROTATE-ITNCT03765866
Rotational Thromboelastometry Activated Transfusion In Trauma Trial
A study testing Thromboelastometry guided transfusion in people with Trauma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Trauma
- What is being tested?
- Thromboelastometry guided transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 17 Dec 2018
- 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 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Trauma patient
- MTP Activation
- Only patients ≥ 14 years old
- Alive at 31 mins after arrival in ED
Who cannot join
- Transfer from OSH
- Received CPR for more than 5 mins
- Burned
- Pregnant or Prisoner
- Known DNR
- Jehovah's witness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients
This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.
Read the detailed description
This is an open labeled study as the VE guided resuscitation will be based on the visible VE results. Aim 1 will compare the number of blood products utilized in each resuscitation strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.
- Conditions
- Trauma
- Being tested
- Thromboelastometry guided transfusion
- Keywords
- rotational thromboelastometry, viscoelastic test, coagulopathy, trauma, hemorrhage
- Medical subject headings
- Wounds and Injuries, Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thromboelastometry guided transfusionProcedure or surgery
Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP
| Study group | Role | What they receive |
|---|---|---|
| Massive Transfusion Protocol Guided | No intervention | Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP) |
| Thromboelastometry guided transfusion | Experimental | Clinicians will transfuse patients according to ROTEM results. Receives: Procedure: Thromboelastometry guided transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of blood products utilized at 24 hours
Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences
Measured: 24 hours from time of randomization
Secondary outcomes (3)
Change in coagulation profile
Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
Measured: 0 hours and 30 days
Change in inflammatory mediators
Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
Measured: 0 hours and 30 days
Changes in Resuscitation strategy-related adverse events
Rate of resuscitation strategies-related adverse events as a composite, including (transfusion related acute lung injury, transfusion associated circulatory overload, hyperkalemia, hypocalcemia, allergic reaction, hemolysis and transfusion transmitted infection)
Measured: 30 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study startMay 2016
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
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 TraumaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael W. Cripps, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765866
- Sponsor's protocol ID
- 022015-093
- Acronym
- ROTATE-IT
- Status last verified
- May 2020
- First submitted
- 23 May 2016
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schochl H. Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study. Scand J Trauma Resusc Emerg Med. 2013 Oct 8;21:74. doi: 10.1186/1757-7241-21-74.
PubMed 24103457
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients
- ClinicalTrials.gov ID
- NCT03765866
- Acronym / sponsor ID
- ROTATE-IT / 022015-093
- Conditions
- Trauma
- Keywords
- rotational thromboelastometry, viscoelastic test, coagulopathy, trauma, hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 5 Dec 2018 (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 randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.
Detailed description
This is an open labeled study as the VE guided resuscitation will be based on the visible VE results. Aim 1 will compare the number of blood products utilized in each resuscitation strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massive Transfusion Protocol Guided | No intervention | –Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP) |
| Thromboelastometry guided transfusion | Experimental | Procedure: Thromboelastometry guided transfusionClinicians will transfuse patients according to ROTEM results. |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Trauma patient
- MTP Activation
- Only patients ≥ 14 years old
- Alive at 31 mins after arrival in ED
Key exclusion criteria (6 listed)
- Transfer from OSH
- Received CPR for more than 5 mins
- Burned
- Pregnant or Prisoner
- Known DNR
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 |
|---|---|---|
| Thromboelastometry guided transfusionComparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP | Procedure or surgery | Thromboelastometry guided transfusion |
Primary outcome
Change in number of blood products utilized at 24 hours
Time frame: 24 hours from time of randomization
Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences
3 secondary outcomes
Change in coagulation profile
Time frame: 0 hours and 30 days
Change in inflammatory mediators
Time frame: 0 hours and 30 days
Changes in Resuscitation strategy-related adverse events
Time frame: 30 days after admission
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 29 May 2020.
- Background: PubMed 24103457Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schochl H. Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study. Scand J Trauma Resusc Emerg Med. 2013 Oct 8;21:74. doi: 10.1186/1757-7241-21-74.
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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.
Michael W. Cripps, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thromboelastometry guided transfusion in people with Trauma, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 4 inclusion and 6 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 29 May 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 United States. 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?
Change in number of blood products utilized at 24 hours (time frame: 24 hours from time of randomization). 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 NCT03765866, 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 29 May 2020.