Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. (PRETIC)

Transfusion of Red Blood Cells (RBC), Tranexamic Acid (TXA) and Fibrinogen Concentrate (FC) for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. A Pilot Trial.

This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC) with the current treatment based on the administration of Crystalloids and TXA.

Study Overview

• Status: Completed
• Conditions: Polytrauma; Traumatic Hemorrhage
• Intervention / Treatment: Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]; Biological: Red blood cells concentrate; Drug: Tranexamic Acid

Detailed Description

A pilot, non-randomized, open-label study of two intervention arms and controlled with the standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma will enter the study with the main objective of evaluating the feasibility and the efficacy of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen concentrate and tranexamic acid (experimental arm) compared to the standard treatment based on crystalloids administration and tranexamic acid (control arm). The secondary objectives are to evaluate the safety and clinical evolution of the patients. Prior to the administration of the treatment, 2 blood samples will be extracted in both groups in order to compare the coagulation status and to be able to perform the pre-transfusion tests. On arrival at the hospital, another sample will be taken to compare changes in coagulation after the administration of the experimental or standard treatment and also between both groups. The assessment of the coagulation status will be made using the values provided by the viscoelastic test (TEG6s). The experimental and standard treatment will be administered endovenously. After treatment, patients will be evaluated up to 30 days.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Girona, Spain, 17007
    • Hospital Josep Trueta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years AND
• Patients with severe trauma categorized as priority 0 or 1 according to the CatSalut Polytrauma Code (PPT) AND
• Evidence of bleeding or a high bleeding suspicion according to physician judgment OR
• Predicted to need transfusion according to TICCS score ≥10

Exclusion Criteria:

• Moribund patient with devastating injuries and expected to die within 1-hour OR
• Known objection to blood components transfusion OR
• Known acquired or congenital coagulopathies not related to the actual trauma OR
• Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR
• Known Pregnancy OR
• Severe isolated traumatic brain injury OR
• Hemorrhage not related to the actual trauma

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental treatment; The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care.	Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]; Administration of 2 mg of FC together with RBC and TXA; Biological: Red blood cells concentrate; Administration of 2 red blood cells concentrates together with FC and TXA; Drug: Tranexamic Acid; Administration of 1g of TXA together with FC and RBC
Active Comparator: Standard treatment; Patients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration.	Drug: Tranexamic Acid; Administration of 1g of TXA together with FC and RBC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)	TEG6s(R) parameters that define TIC	Basal (at the crash site)
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)	TEG6s(R) parameters that define TIC	Basal (at the hospital arrival)
All-cause mortality	Mortality for any cause	1 hour post hospital admission
All-cause mortality	Mortality for any cause	6 hours post hospital admission
All-cause mortality	Mortality for any cause	24 hours post hospital admission
Accountability	Red bood cells concentrate accountability	30 days
Temperature storage conditions of the red blood cells concentrate	Red bood cells concentrate out of temperature range for storage	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Mortality for any cause	48 hours post hospital admission
All-cause mortality	Mortality for any cause	30 days post hospital admission
Adverse Events	Treatment emergent adverse events	30 days post hospital admission (or previously at hospital discharge)
Thromboembolism events	Thromboembolism events	30 days
Crystalloid fluid requirements	Volume of crystalloids required	1 hour (from the crash site to the hospital admission)
Crystalloid fluid requirements	Volume of crystalloids required	30 days post hospital admission (or previously at hospital discharge)
Transfusion requirements	Transfusion requirements of RBC, platelets and plasma	24 hours (or previously at discharge of the emergency room)
Transfusion requirements	Transfusion requirements of RBC, platelets and plasma	30 days post hospital admission (or previously at hospital discharge)
Water balance	Water balance at the Intensive Care Unit (ICU)	24 hours of admission at the ICU
Water balance	Water balance at the Intensive Care Unit (ICU)	72 hours of admission at the ICU
Ventilator-free days	Ventilator-free days at the ICU	30 days

Collaborators and Investigators

• Sponsor: Banc de Sang i Teixits
• Collaborators: Sistema d'Emergències Mèdiques (SEM); IDIBGI (Institut d'Investigació Biomèdica de Girona Dr. Trueta)

Publications and helpful links

Helpful Links

• Blood and Tissue Bank of Catalonia
• HOspital Universitari Dr. Trueta (Girona, Spain)

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): January 11, 2022

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Polytrauma; Red blood cells transfusion; Acute traumatic hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage; Multiple Trauma; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: PRETIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No