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

Polytrauma Clinical Trial

— PRETIC  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780894
• Other study ID #: PRETIC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 21, 2018
• Est. completion date: January 11, 2022

Study information

• Verified date: January 2024
• Source: Banc de Sang i Teixits
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 11, 2022
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Multiple Trauma
• Polytrauma
• Traumatic Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Josep Trueta	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Banc de Sang i Teixits

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)	TEG6s(R) parameters that define TIC	Basal (at the crash site)
Primary	TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)	TEG6s(R) parameters that define TIC	Basal (at the hospital arrival)
Primary	All-cause mortality	Mortality for any cause	1 hour post hospital admission
Primary	All-cause mortality	Mortality for any cause	6 hours post hospital admission
Primary	All-cause mortality	Mortality for any cause	24 hours post hospital admission
Primary	Accountability	Red bood cells concentrate accountability	30 days
Primary	Temperature storage conditions of the red blood cells concentrate	Red bood cells concentrate out of temperature range for storage	24 hours
Secondary	All-cause mortality	Mortality for any cause	48 hours post hospital admission
Secondary	All-cause mortality	Mortality for any cause	30 days post hospital admission
Secondary	Adverse Events	Treatment emergent adverse events	30 days post hospital admission (or previously at hospital discharge)
Secondary	Thromboembolism events	Thromboembolism events	30 days
Secondary	Crystalloid fluid requirements	Volume of crystalloids required	1 hour (from the crash site to the hospital admission)
Secondary	Crystalloid fluid requirements	Volume of crystalloids required	30 days post hospital admission (or previously at hospital discharge)
Secondary	Transfusion requirements	Transfusion requirements of RBC, platelets and plasma	24 hours (or previously at discharge of the emergency room)
Secondary	Transfusion requirements	Transfusion requirements of RBC, platelets and plasma	30 days post hospital admission (or previously at hospital discharge)
Secondary	Water balance	Water balance at the Intensive Care Unit (ICU)	24 hours of admission at the ICU
Secondary	Water balance	Water balance at the Intensive Care Unit (ICU)	72 hours of admission at the ICU
Secondary	Ventilator-free days	Ventilator-free days at the ICU	30 days

External Links

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