Wounds and InjuriesPhase 4STATANCT02416817
Strategy of Transfusion in Trauma Patients - STATA Trial
A Phase 4 study testing Blood Products only and Point of Care guided in people with Wounds and Injuries, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to compare two already validated methods for massive transfusion in trauma patients admitted to the emergency room of a large reference hospital. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Blood Products only and Point of Care guided
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Jul 2016
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma victims
- Adults between 18 - 80 years old
- Injury Severity Score (ISS) between 15 and 45
- Assessment of Blood Consumption (ABC) Score ≥ 3 points
- Shock Index ≥ 1,2
Who cannot join
- Early cardiac arrest
- Pregnancy
- ISS > 45
- Patient transferred from another hospital
- Drug abuse history
- Known coagulation impairment
- Known use of anticoagulants, or platelet anti-aggregants. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial: Evaluation of 2 Different Protocols of Blood Derivates Transfusion in Acute Trauma Patients in a Brazilian Tertiary Hospital
The purpose of this study is to compare two already validated methods for massive transfusion in trauma patients admitted to the emergency room of a large reference hospital.
Read the detailed description
In this randomized trial trauma patients in need of massive transfusion will be assigned to one of the following transfusion strategies:
- - Fresh Frozen Plasma, Platelets Concentrate and Packed red blood cells in 1:1:1 ratio.
- - These patients will receive Red blood cells based on Haemoglobin measurements and will receive either Beriplex® P/N (CSL Behring GmbH, Marburg, Germany) or Haemocomplettan® P (CSL Behring, Marburg, Germany), or Platelets based on thromboelastometry.
To be included patients must meet the following inclusion criteria:
- - Trauma victims
- - Adults between 18 - 80 years old
- - Injury Severity Score (ISS) between 15 and 45
- - Assessment of Blood Consumption (ABC) Score ≥ 3 points
- - Shock Index ≥ 1,2
- - Acute hemorrhage of more than 50% estimated blood volume in 3 hours or more than 1,5 ml/kg/min of blood during 20 minutes.
Exclusion Criteria:
- - Early cardiac arrest
- - Pregnancy
- - Injury Severity Score (ISS) > 45
- - Patient transferred from another hospital
- - Drug abuse history
- - Known coagulation impairment
- - Known use of anticoagulants, or platelet antiaggregants.
The group of health-care providers recruiting the patients based on eligibility criteria, is different than the group that evaluates the clinical outcomes of the included patients, in such a way that no researcher is tasked with post-randomisation care of the subjects. This is done to prevent observational bias.
Two informed consent forms are signed for each patient. The first one is signed by an independent physician. Another consent form is signed by the patient's family or the own patient within 24 hours of hospital admission.
The randomisation is performed by sealed envelopes assigned to the eligible patients anytime they reach the protocol criteria. The envelopes were created using a computer generated randomisation table specifically designed to this study.
An interim analysis was performed in October 2015 and it showed that there was no increased mortality or morbidity within the intervention group.
- Conditions
- Wounds and Injuries
- Being tested
- Blood Products only, Point of Care guided
- Keywords
- Thrombelastography, Massive Transfusion, Major Trauma, Blood products, Thromboelastometry
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Products onlyOther
Also called Red blood cells, Platelets, Fresh frozen plasma
Based solely on massive transfusion triggers Patients with traumatic hemorrhage that fulfil the inclusion criteria will receive blood products by prescription of the patient's anesthesiologist. The patient will be constantly observed and bleeding triggers will be reassessed hourly.
Point of Care guidedOther
Also called Red blood cells, Beriplex® P/N (CSL Behring GmbH, Marburg, Germany), Haemocomplettan® P (CSL Behring, Marburg, Germany), Prothrombin Complex Concentrates (PCC)
Based on massive transfusion triggers and thromboelastometry Patients with traumatic hemorrhage that fulfil the inclusion criteria will receive the drugs guided by the results of the thromboelastometry. The dosis of each drug will be based on the analysis of the thromboelastometry curves (established algorithm).
| Study group | Role | What they receive |
|---|---|---|
| Blood Products only. | Experimental | This arm will receive 1:1:1 Red blood cells : Fresh Frozen Plasma : Platelets upon a major trauma triggers. 1:1:1 Ratio for packs of blood products. The patient will be re-evaluated every hour again for the major bleeding triggers and another 1:1:1 intervention may or may not occur. Receives: Other: Blood Products only |
| Point of care guided | Experimental | This arm will receive Red blood cells, Human Fibrinogen and Prothrombinic complex concentrates (PCC) based on thromboelastometry. The dosis of each drug will be determined by the analyses of the thromboelastometry curves. Receives: Other: Point of Care guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA Score - 5 days
Evaluation of the SOFA score along the first 5 days after the patient admission.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
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 Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roseny R Rodrigues, M.D., Study director, Hospital das Clínicas HC-FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416817
- Sponsor's protocol ID
- STATA
- Acronym
- STATA
- Status last verified
- Nov 2015
- First submitted
- 28 Aug 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual patient data collected can be shared if needed.
Publications
Brunskill SJ, Disegna A, Wong H, Fabes J, Desborough MJ, Doree C, Davenport R, Curry N, Stanworth SJ. Blood transfusion strategies for major bleeding in trauma. Cochrane Database Syst Rev. 2025 Apr 24;4(4):CD012635. doi: 10.1002/14651858.CD012635.pub2.
PubMed 40271704
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial: Evaluation of 2 Different Protocols of Blood Derivates Transfusion in Acute Trauma Patients in a Brazilian Tertiary Hospital
- ClinicalTrials.gov ID
- NCT02416817
- Acronym / sponsor ID
- STATA / STATA
- Conditions
- Wounds and Injuries
- Keywords
- Thrombelastography, Massive Transfusion, Major Trauma, Blood products, Thromboelastometry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Apr 2015 (estimated)
- 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.
The purpose of this study is to compare two already validated methods for massive transfusion in trauma patients admitted to the emergency room of a large reference hospital.
Detailed description
In this randomized trial trauma patients in need of massive transfusion will be assigned to one of the following transfusion strategies:
- - Fresh Frozen Plasma, Platelets Concentrate and Packed red blood cells in 1:1:1 ratio.
- - These patients will receive Red blood cells based on Haemoglobin measurements and will receive either Beriplex® P/N (CSL Behring GmbH, Marburg, Germany) or Haemocomplettan® P (CSL Behring, Marburg, Germany), or Platelets based on thromboelastometry.
To be included patients must meet the following inclusion criteria:
- - Trauma victims
- - Adults between 18 - 80 years old
- - Injury Severity Score (ISS) between 15 and 45
- - Assessment of Blood Consumption (ABC) Score ≥ 3 points
- - Shock Index ≥ 1,2
- - Acute hemorrhage of more than 50% estimated blood volume in 3 hours or more than 1,5 ml/kg/min of blood during 20 minutes.
Exclusion Criteria:
- - Early cardiac arrest
- - Pregnancy
- - Injury Severity Score (ISS) > 45
- - Patient transferred from another hospital
- - Drug abuse history
- - Known coagulation impairment
- - Known use of anticoagulants, or platelet antiaggregants.
The group of health-care providers recruiting the patients based on eligibility criteria, is different than the group that evaluates the clinical outcomes of the included patients, in such a way that no researcher is tasked with post-randomisation care of the subjects. This is done to prevent observational bias.
Two informed consent forms are signed for each patient. The first one is signed by an independent physician. Another consent form is signed by the patient's family or the own patient within 24 hours of hospital admission.
The randomisation is performed by sealed envelopes assigned to the eligible patients anytime they reach the protocol criteria. The envelopes were created using a computer generated randomisation table specifically designed to this study.
An interim analysis was performed in October 2015 and it showed that there was no increased mortality or morbidity within the intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Products only. | Experimental | Other: Blood Products onlyThis arm will receive 1:1:1 Red blood cells : Fresh Frozen Plasma : Platelets upon a major trauma triggers. 1:1:1 Ratio for packs of blood products. The patient will be re-evaluated every hour again for the major bleeding triggers and another 1:1:1 intervention may or may not occur. |
| Point of care guided | Experimental | Other: Point of Care guidedThis arm will receive Red blood cells, Human Fibrinogen and Prothrombinic complex concentrates (PCC) based on thromboelastometry. The dosis of each drug will be determined by the analyses of the thromboelastometry curves. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Trauma victims
- Adults between 18 - 80 years old
- Injury Severity Score (ISS) between 15 and 45
- Assessment of Blood Consumption (ABC) Score ≥ 3 points
- Shock Index ≥ 1,2
Key exclusion criteria (7 listed)
- Early cardiac arrest
- Pregnancy
- ISS > 45
- Patient transferred from another hospital
- Drug abuse history
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 |
|---|---|---|
| Blood Products onlyAlso: Red blood cells, Platelets, Fresh frozen plasmaBased solely on massive transfusion triggers Patients with traumatic hemorrhage that fulfil the inclusion criteria will receive blood products by prescription of the patient's anesthesiologist. The patient will be constantly observed and bleeding triggers will be reassessed hourly. | Other | Blood Products only. |
| Point of Care guidedAlso: Red blood cells, Beriplex® P/N (CSL Behring GmbH, Marburg, Germany), Haemocomplettan® P (CSL Behring, Marburg, Germany), Prothrombin Complex Concentrates (PCC)Based on massive transfusion triggers and thromboelastometry Patients with traumatic hemorrhage that fulfil the inclusion criteria will receive the drugs guided by the results of the thromboelastometry. The dosis of each drug will be based on the analysis of the thromboelastometry curves (established algorithm). | Other | Point of care guided |
Primary outcome
SOFA Score - 5 days
Time frame: 5 days
Evaluation of the SOFA score along the first 5 days after the patient 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 2 Nov 2016.
- Derived from this study: PubMed 40271704Brunskill SJ, Disegna A, Wong H, Fabes J, Desborough MJ, Doree C, Davenport R, Curry N, Stanworth SJ. Blood transfusion strategies for major bleeding in trauma. Cochrane Database Syst Rev. 2025 Apr 24;4(4):CD012635. doi: 10.1002/14651858.CD012635.pub2.
- Individual participant dataSharing planned: Yes. Individual patient data collected can be shared if needed.
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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.
Roseny R Rodrigues, M.D. study director
Hospital das Clínicas HC-FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood Products only and Point of Care guided in people with Wounds and Injuries, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 7 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 Nov 2016. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
SOFA Score - 5 days (time frame: 5 days). 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 NCT02416817, 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 2 Nov 2016.