Phase 4
Completed N=107
Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Trauma/Injury Problem
Source: ClinicalTrials.gov NCT01227005 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Units of Blood Products Required During the First 24 Hours After Emergency Department Admission — 12; 13 units of blood
Summary
The proposal will assess if patients who require massive transfusion can be accurately predicted early after emergency department arrival and assess if the use of stored whole blood during initial resuscitation will reduce transfusion needs compared to transfusion with component therapy and thus improve outcome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Units of Blood Products Required During the First 24 Hours After Emergency Department Admission |
12; 13 | — |
| SECONDARY 24-hour Mortality |
12; 7 | — |
| SECONDARY 30-day Mortality |
15; 8 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older.
- Meet Code 3 status; Code 3 is determined by the following criteria (Patients must meet at least one of the following physiologic and/or anatomic criteria):
- Physiologic criteria indicating high risk or life threatening injuries
- GCS 29 (Respiratory rate)
- HR >120 (Heart rate)
- intubated
- Base Deficit > 6
- Anatomic criteria indicating high risk or life threatening injuries
- Any penetrating injury to torso, groin, or neck
- Amputation proximal to the ankle or wrist
- Uncontrolled external hemorrhage
- Two or more long bone fractures
- Pelvic fracture
- Paraplegia or quadriplegia
- Combination trauma with burns ≥ 20% BSA (body surface area)
- Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED.
Exclusion Criteria
- Death thought to be imminent, suggesting a futile resuscitation effort
- Known or assumed religious objection to blood products
- Do not resuscitate order in place
- Women who present to the ED who are obviously pregnant.
- Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community consultation.
Data sourced from ClinicalTrials.gov (NCT01227005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.