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Completed

NCT Number: NCT03780894

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

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.

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Key information

Conditions

Polytrauma Multiple Trauma Traumatic Hemorrhage Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Josep Trueta

Girona, 17007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

Drug

Administration of 2 mg of FC together with RBC and TXA

Red blood cells concentrate

Biological

Administration of 2 red blood cells concentrates together with FC and TXA

Tranexamic Acid

Drug

Administration of 1g of TXA together with FC and RBC

Primary outcomes

  1. TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)

    Time frame: Basal (at the crash site)

    TEG6s(R) parameters that define TIC

  2. TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)

    Time frame: Basal (at the hospital arrival)

    TEG6s(R) parameters that define TIC

  3. All-cause mortality

    Time frame: 1 hour post hospital admission

    Mortality for any cause

  4. All-cause mortality

    Time frame: 6 hours post hospital admission

    Mortality for any cause

  5. All-cause mortality

    Time frame: 24 hours post hospital admission

    Mortality for any cause

  6. Accountability

    Time frame: 30 days

    Red bood cells concentrate accountability

  7. Temperature storage conditions of the red blood cells concentrate

    Time frame: 24 hours

    Red bood cells concentrate out of temperature range for storage

Secondary outcomes

  1. All-cause mortality

    Time frame: 48 hours post hospital admission

    Mortality for any cause

  2. All-cause mortality

    Time frame: 30 days post hospital admission

    Mortality for any cause

  3. Adverse Events

    Time frame: 30 days post hospital admission (or previously at hospital discharge)

    Treatment emergent adverse events

  4. Thromboembolism events

    Time frame: 30 days

    Thromboembolism events

  5. Crystalloid fluid requirements

    Time frame: 1 hour (from the crash site to the hospital admission)

    Volume of crystalloids required

  6. Crystalloid fluid requirements

    Time frame: 30 days post hospital admission (or previously at hospital discharge)

    Volume of crystalloids required

  7. Transfusion requirements

    Time frame: 24 hours (or previously at discharge of the emergency room)

    Transfusion requirements of RBC, platelets and plasma

  8. Transfusion requirements

    Time frame: 30 days post hospital admission (or previously at hospital discharge)

    Transfusion requirements of RBC, platelets and plasma

  9. Water balance

    Time frame: 24 hours of admission at the ICU

    Water balance at the Intensive Care Unit (ICU)

  10. Water balance

    Time frame: 72 hours of admission at the ICU

    Water balance at the Intensive Care Unit (ICU)

  11. Ventilator-free days

    Time frame: 30 days

    Ventilator-free days at the ICU

Sponsors and collaborators

Lead sponsor

Banc de Sang i Teixits

Other

Registry information

Official study 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.

Acronym: PRETIC

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Dec 19, 2018
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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