Strategy of Transfusion in Trauma Patients - STATA Trial

NCT02416817 | Completed Phase 4

• 1 other identifier: STATA
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Keywords

Thrombelastography; Massive Transfusion; Major Trauma; Blood products; Thromboelastometry

Outcome Measures

Primary Outcomes (1)

• SOFA Score - 5 days

  Evaluation of the SOFA score along the first 5 days after the patient admission.

  5 days

Study Arms (2)

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.

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.

Other: Point of Care guided

Interventions

Blood Products only OTHER

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.

Also known as: Red blood cells, Platelets, Fresh frozen plasma

Blood Products only.

Point of Care guided OTHER

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).

Also known as: Red blood cells, Beriplex® P/N (CSL Behring GmbH, Marburg, Germany), Haemocomplettan® P (CSL Behring, Marburg, Germany), Prothrombin Complex Concentrates (PCC), Human Fibrinogen

Point of care guided

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 40271704 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Erythrocyte Count; Platelet Count; prothrombin complex concentrates; Fibrinogen

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Platelet Function Tests; Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Study Officials

• Roseny R Rodrigues, M.D.

  Hospital das Clínicas HC-FMUSP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: April 15, 2015
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 2, 2016

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)