Status:
COMPLETED
Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Trauma/Injury Problem
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief 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 res...
Detailed Description
Background: The acquired coagulopathy of trauma is responsible for a large percentage of early deaths in civilian trauma practice and is a major cause of battlefield mortality. Widespread recognition ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01227005
Start Date
May 1 2011
End Date
December 1 2012
Last Update
June 4 2018
Active Locations (1)
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1
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States, 77030