Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Completed · Phase 4
Conditions studied: Trauma/Injury Problem
In brief
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.
Key facts
- Study ID
- NCT01227005
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 107
- Starts
- 2011-05-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2018-06-04
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 <10 (Glasgow Coma Scale)
- SBP <90 (Systolic blood pressure)
- RR <10 or >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.
You may not qualify if…
- 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.
Where it is running
- Memorial Hermann Hospital - Texas Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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