Strategy of Transfusion in Trauma Patients - STATA Trial

NCT ID: NCT02416817

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Wounds and Injuries

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Blood Products only

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Point of Care guided

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

Other Intervention Names

Red blood cells; Platelets; Fresh frozen plasma; Red blood cells; Beriplex® P/N (CSL Behring GmbH, Marburg, Germany); Haemocomplettan® P (CSL Behring, Marburg, Germany); Prothrombin Complex Concentrates (PCC); Human Fibrinogen

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roseny R Rodrigues, M.D.

Role: STUDY_DIRECTOR

Hospital das Clínicas HC-FMUSP

Locations

Hospital das Clínicas FMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 40271704 (View on PubMed)

Other Identifiers

STATA

Identifier Type: -

Identifier Source: org_study_id