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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02416817
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Other: Blood Products only Other: Point of Care guided Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. SOFA Score - 5 days [ Time Frame: 5 days ]
    Evaluation of the SOFA score along the first 5 days after the patient admission.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. -

Information from the National Library of Medicine

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


Locations
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Brazil
Hospital das Clínicas FMUSP
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Director: Roseny R Rodrigues, M.D. Hospital das Clínicas HC-FMUSP
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02416817    
Other Study ID Numbers: STATA
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data collected can be shared if needed.
Keywords provided by University of Sao Paulo General Hospital:
Thrombelastography
Massive Transfusion
Major Trauma
Blood products
Thromboelastometry
Additional relevant MeSH terms:
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Wounds and Injuries
Thrombin
Hemostatics
Coagulants