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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03780894
Other study ID # PRETIC
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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