Strategy of Transfusion in Trauma Patients - STATA Trial (STATA)

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries
• Intervention / Treatment: Other: Blood Products only; Other: Point of Care guided

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-000
      • Hospital das Clinicas FMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Products only.; 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; 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.; Other Names: Red blood cells; Platelets; Fresh frozen plasma
Experimental: Point of care guided; 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; 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 Names: Red blood cells; Beriplex® P/N (CSL Behring GmbH, Marburg, Germany); Haemocomplettan® P (CSL Behring, Marburg, Germany); Prothrombin Complex Concentrates (PCC); Human Fibrinogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA Score - 5 days	Evaluation of the SOFA score along the first 5 days after the patient admission.	5 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Director: Roseny R Rodrigues, M.D., Hospital das Clínicas HC-FMUSP

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Massive Transfusion; Thromboelastometry; Major Trauma; Thrombelastography; Blood products
• Additional Relevant MeSH Terms: Wounds and Injuries; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: STATA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual patient data collected can be shared if needed.