Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers
      designed to determine the efficacy and safety of low titer whole blood resuscitation as
      compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to
      appropriately characterize the hemostatic competency of whole blood relative to its age.

Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial

Hemorrhagic Shock

Traumatic Injury

low titer whole blood

Standard Care

Type O Whole Blood and Assessment of Age During Prehospital Resuscitation (TOWAR) Trial

Professor

Age of units of whole blood in days categorized into young (1-14 days) and old (>14 days) and compared across primary and secondary outcomes

Type of blood or blood component required for transfusion

Number of units of blood or blood component transfused

Amount of time from enrollment to transfusion of blood or blood component

Organ dysfunction will be evaluated via the Denver Post-injury Multiple Organ Failure Score. Patients who are never admitted to the Intensive Care Unit (ICU) or those with a length of ICU stay of less than 48 hours will be considered to have a Denver score of 0. A summary of the Denver score may be calculated by summing the worst scores of each of the individual systems over the course of the ICU stay. A summary Denver score > 3 will be classified as MOF.

Pneumonia acquired during hospitalization per Center for Disease Control (CDC) criteria

Blood stream infection during hospitalization per CDC criteria

The Berlin definition for mild ARDS (PaO2/FIO2, ≤ 300 mm Hg + timing, imaging and origin criteria) will be utilized as a threshold value to determine the incidence of ARDS and will be further stratified into Moderate (PaO2/FIO2, ≤ 200 mm Hg) and Severe (PaO2/FIO2, ≤ 100 mm Hg).

Measurement of platelet hemostatic function

Coagulopathy as indicated by rTEG measures

rTEG measurement of platelet hemostatic function

Ability to reach nadir transfusion requirement of 1 unit of red blood cells in a 60-minute time period in the first 4 hours following arrival

platelet function test using low-dose collagen as a stimulus

Subjects will receive up to two units of whole blood as collected by local blood bank procedures and stored at 1-6 degrees Celsius initiated in the prehospital phase of care.

Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.

Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial

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