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.

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

Polytrauma

Traumatic Hemorrhage

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.

Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]

Red blood cells concentrate

Tranexamic Acid

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.

Red bood cells concentrate accountability

Red bood cells concentrate out of temperature range for storage

Transfusion requirements of RBC, platelets and plasma

Water balance at the Intensive Care Unit (ICU)

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.

Patients in the control arm will be treated according the existing protocols based on
crystalloids and tranexamic acid administration.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status