Strategy of Transfusion in Trauma Patients - STATA Trial

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 4

Conditions: Wounds and Injuries

Treatments: Other: Point of Care guided; Other: Blood Products only

Study type: Interventional

Funder types: Other

Identifiers

NCT02416817

STATA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Blood Products only.

Experimental group

Description:

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.

Treatment:

Other: Blood Products only

Point of care guided

Experimental group

Description:

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.

Treatment:

Other: Point of Care guided