Clinical trial NCT02416817: Strategy of Transfusion in Trauma Patients - STATA Trial
Official title: Clinical Trial: Evaluation of 2 Different Protocols of Blood Derivates Transfusion in Acute Trauma Patients in a Brazilian Tertiary Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wounds and Injuries
Keywords: Thrombelastography
Massive Transfusion
Major Trauma
Blood products
Thromboelastometry
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In this randomized trial trauma patients in need of massive transfusion will be assigned to one of the following transfusion strategies:

1. - Fresh Frozen Plasma, Platelets Concentrate and Packed red blood cells in 1:1:1 ratio.
2. - 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:

1. - Trauma victims
2. - Adults between 18 - 80 years old
3. - Injury Severity Score (ISS) between 15 and 45
4. - Assessment of Blood Consumption (ABC) Score ≥ 3 points
5. - Shock Index ≥ 1,2
6. - 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:

1. - Early cardiac arrest
2. - Pregnancy
3. - Injury Severity Score (ISS) \> 45
4. - Patient transferred from another hospital
5. - Drug abuse history
6. - Known coagulation impairment
7. - 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.

Eligibility criteria: 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

Exclusion Criteria:

* 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. -

Primary outcomes:
measure: SOFA Score - 5 days
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas FMUSP
state: SP
Study officials:
affiliation: Hospital das Clínicas HC-FMUSP
name: Roseny R Rodrigues, M.D.
role: STUDY_DIRECTOR
References: