Strategy of Transfusion in Trauma Patients - STATA Trial (STATA)
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|ClinicalTrials.gov Identifier: NCT02416817|
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : November 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Wounds and Injuries||Other: Blood Products only Other: Point of Care guided||Phase 4|
In this randomized trial trauma patients in need of massive transfusion will be assigned to one of the following transfusion strategies:
- - Fresh Frozen Plasma, Platelets Concentrate and Packed red blood cells in 1:1:1 ratio.
- - 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:
- - 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
- - 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.
- - Early cardiac arrest
- - Pregnancy
- - Injury Severity Score (ISS) > 45
- - Patient transferred from another hospital
- - Drug abuse history
- - Known coagulation impairment
- - 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 (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial: Evaluation of 2 Different Protocols of Blood Derivates Transfusion in Acute Trauma Patients in a Brazilian Tertiary Hospital|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
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.
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).
- SOFA Score - 5 days [ Time Frame: 5 days ]Evaluation of the SOFA score along the first 5 days after the patient admission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416817
|Hospital das Clínicas FMUSP|
|Sao Paulo, SP, Brazil, 05403-000|
|Study Director:||Roseny R Rodrigues, M.D.||Hospital das Clínicas HC-FMUSP|