Strategy of Transfusion in Trauma Patients - STATA Trial

Wounds and Injuries Clinical Trial

— STATA  

Official title:

Clinical Trial: Evaluation of 2 Different Protocols of Blood Derivates Transfusion in Acute Trauma Patients in a Brazilian Tertiary Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416817
• Other study ID #: STATA
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2014
• Last updated: November 1, 2016
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

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.
• 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).

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas FMUSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SOFA Score - 5 days	Evaluation of the SOFA score along the first 5 days after the patient admission.	5 days	No