Phase
Condition
N/ATreatment
Components
LTOWB
Clinical Study ID
Ages > 15 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult trauma patient (estimated age > 15 or weight > 50 kg, if age unknown)
Patient taken to trauma center directly from scene
Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital orin-hospital setting
Activation of site-specific Massive Hemorrhage Protocol or Massive TransfusionProtocol
Traumatic injury with at least one of the following:
Confirmed or suspected acute major bleeding
Assessment of Blood Consumption (ABC) Score ≥2
Exclusion
Exclusion Criteria:
Patients who have received, prehospital or in-hospital more than two units of LTOWB;the equivalent in components (two units of packed red blood cells and two units ofplasma); or a combination of the two (more than one unit of LTOWB, one unit ofpacked cells, and one unit of plasma). Most trauma centers hold two units of eitherpacked red blood cells (with two units of plasma) or two units of LTOWB in theemergency department. This stock is used to initiate transfusion, while the massivehemorrhage protocol is activated from the blood bank.
Patients transferred from another hospital
Children <15 years (in most communities, patients aged 15-18 years are treated atadult trauma centers, and patients in this age group frequently sufferlife-threatening injuries, and will therefore be included)
Known prisoners, defined as individuals involuntarily confined or detained in apenal institution (including juvenile detention, involuntary psychiatric commitment,or court-ordered residential substance abuse treatment)
Moribund patients expected to die within 1 hour
Patients who required an ED thoracotomy or received more than 5 consecutive minutesof cardiopulmonary resuscitation (prior to receiving randomized blood products)
Patients with known "do not resuscitate" orders prior to randomization
Patients who refuse the administration of blood products
Individuals with a research "opt out" bracelet.
Greater than 20% total body surface area (TBSA) burns
Suspected inhalation injury victims
Patients who are obviously pregnant on clinical examination or known to be pregnantas provided by the subject or legally authorized representative
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham, UAB Hospital
Birmingham, Alabama 35294
United StatesActive - Recruiting
Los Angeles County + University of Southern California (LAC + USC) Medical Center
Los Angeles, California 90033
United StatesSite Not Available
University Medical Center New Orleans LCMC Health
New Orleans, Louisiana 70112
United StatesSite Not Available
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St. Louis, Missouri 63110
United StatesSite Not Available
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
United StatesActive - Recruiting
Oregon Health and Sciences University Hospital
Portland, Oregon 97239
United StatesSite Not Available
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Texas Health Science Center Houston
Houston, Texas 77030
United StatesSite Not Available
University of Texas Health San Antonio and University Health System
San Antonio, Texas 78229
United StatesSite Not Available
Harborview Medical Center
Seattle, Washington 98104
United StatesActive - Recruiting
Froedtert Hospital
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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