Gender and Age
Item
Male or female, 18 - 80 years of age (inclusive)
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
major trauma and admitted to emergency department, ICU, step-down or equivalent unit
Item
Patients with major trauma admitted to the emergency department, ICU, step-down, or equivalent unit
boolean
C0205404 (UMLS CUI [1,1])
C3714660 (UMLS CUI [1,2])
C0583239 (UMLS CUI [2])
C0583237 (UMLS CUI [3])
C1627345 (UMLS CUI [4,1])
C0030673 (UMLS CUI [4,2])
C0030673 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C0019988 (UMLS CUI [5,3])
Injury Severity score
Item
Injury Severity score (ISS) >=16 to <70
boolean
C0021504 (UMLS CUI [1])
Females of non-child-bearing potential or contraception
Item
A female subject is eligible to participate if she is of non-child-bearing potential or of child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator, if applicable).
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Male contraception
Item
Male subjects must agree to use one of the contraception methods listed in Section 8.1, if applicable. This criterion must be followed from the time of the first dose of study medication until one week post-last dose, if applicable
boolean
C0086580 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
BMI
Item
BMI within the range 19.0 - 40.0 kg/m2 inclusive
boolean
C1305855 (UMLS CUI [1])
Informed Consent and Compliance
Item
The subject or legal decision maker is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
QTcB or QTcF time or QTC in subjects with Bundle Branch Block
Item
QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
boolean
C1882513 (UMLS CUI [1])
C1882512 (UMLS CUI [2])
C0489625 (UMLS CUI [3,1])
C0006384 (UMLS CUI [3,2])
Time between trauma and randomization
Item
The subject must be randomized into the study within 24-26 hours from the time of trauma.
boolean
C1272706 (UMLS CUI [1,1])
C3714660 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Known HbsAg or HCV antibody
Item
Known positive Hepatitis B surface antigen or Hepatitis C antibody.
boolean
C0205309 (UMLS CUI [1,1])
C0149709 (UMLS CUI [1,2])
C0205309 (UMLS CUI [2,1])
C0281863 (UMLS CUI [2,2])
Known positive HIV antibody
Item
Known positive test for HIV antibody
boolean
C0920548 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
Recent history of substance abuse or alcohol abuse causing liver disease such as cirrhosis, chronic ascites or portal hypertension, or recent withdrawal syndrome
Item
A known history of substance abuse or alcohol abuse, within 6 months of the study causing chronic liver disease such as cirrhosis, chronic ascites or portal hypertension, or known evidence of withdrawal syndrome within the past 6 months.
boolean
C0332185 (UMLS CUI [1,1])
C0085762 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0341439 (UMLS CUI [1,4])
C0332185 (UMLS CUI [2,1])
C0038586 (UMLS CUI [2,2])
C0678227 (UMLS CUI [2,3])
C0341439 (UMLS CUI [2,4])
C0332185 (UMLS CUI [3,1])
C0085762 (UMLS CUI [3,2])
C0678227 (UMLS CUI [3,3])
C0023890 (UMLS CUI [3,4])
C0332185 (UMLS CUI [4,1])
C0038586 (UMLS CUI [4,2])
C0678227 (UMLS CUI [4,3])
C0023890 (UMLS CUI [4,4])
C0332185 (UMLS CUI [5,1])
C0085762 (UMLS CUI [5,2])
C0678227 (UMLS CUI [5,3])
C0008679 (UMLS CUI [5,4])
C0003962 (UMLS CUI [5,5])
C0332185 (UMLS CUI [6,1])
C0038586 (UMLS CUI [6,2])
C0678227 (UMLS CUI [6,3])
C0008679 (UMLS CUI [6,4])
C0003962 (UMLS CUI [6,5])
C0332185 (UMLS CUI [7,1])
C0085762 (UMLS CUI [7,2])
C0678227 (UMLS CUI [7,3])
C0020541 (UMLS CUI [7,4])
C0332185 (UMLS CUI [8,1])
C0038586 (UMLS CUI [8,2])
C0678227 (UMLS CUI [8,3])
C0020541 (UMLS CUI [8,4])
C0332185 (UMLS CUI [9,1])
C0038587 (UMLS CUI [9,2])
Recent clinical trial participation with recent investigational product administration
Item
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
boolean
C2348568 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Sensitivity to study medications or their components, or drug or other allergy contraindicating participation
Item
History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0205394 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
C1301624 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
Hemoglobin
Item
Hemoglobin < 7g/dL.
boolean
C0019046 (UMLS CUI [1])
Pregnancy (by serum or urine hCG test)
Item
Pregnant females as determined by positive serum or urine hCG test prior to dosing
boolean
C0032961 (UMLS CUI [1])
C0430056 (UMLS CUI [2])
C0430060 (UMLS CUI [3])
Lactating females
Item
Lactating females.
boolean
C2828358 (UMLS CUI [1])
Unwillingness or inability to follow protocol
Item
Unwillingness or inability to follow the procedures outlined in the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
sensitivity to heparin or heparin-induced thrombocytopenia
Item
History of sensitivity to heparin or heparin-induced thrombocytopenia
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
ALI at admission
Item
Diagnosis of ALI at admission
boolean
C0242488 (UMLS CUI [1,1])
C0030673 (UMLS CUI [1,2])
Head trauma by AIS, uncontrolled intracranial hypertension by ICP, liver trauma by score, or trauma deemed unsurvivable
Item
Head trauma (Abbreviated Injury Score [AIS]>4) or evidence of uncontrolled intracranial hypertension (ICP >20 mmHg despite therapy), liver trauma (AIS>2), or trauma that in the opinion of the Principle Investigator or GSK medical monitor is deemed unsurvivable
boolean
C0018674 (UMLS CUI [1,1])
C0000722 (UMLS CUI [1,2])
C0151740 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0021880 (UMLS CUI [3])
C0000722 (UMLS CUI [4,1])
C0160390 (UMLS CUI [4,2])
C0871010 (UMLS CUI [5,1])
C3714660 (UMLS CUI [5,2])
C3151529 (UMLS CUI [5,3])
Known history of neuromuscular disease or high cord injury
Item
Known history of neuromuscular disease or cord injury at C5 or above
boolean
C0205309 (UMLS CUI [1,1])
C0027868 (UMLS CUI [1,2])
C0037929 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
ALT
Item
Elevated ALT > 5x ULN
boolean
C0201836 (UMLS CUI [1])
History of bone marrow or solid organ transplant
Item
History of bone marrow or solid organ transplant
boolean
C0730400 (UMLS CUI [1])
C0005961 (UMLS CUI [2])
auto-immune disorder requiring recent immunosuppressive agents other than prednisone
Item
Known history of auto-immune disorder in which immunosuppressive agents, other than prednisone, were required within the last 6 weeks
boolean
C0004364 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1555447 (UMLS CUI [1,3])
C0021081 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
recent oral or intravenous corticosteroids
Item
Known to be receiving oral or intravenous corticosteroids within 7 days of admission
boolean
C0001617 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0348016 (UMLS CUI [2,2])
C0001617 (UMLS CUI [2,3])
active tuberculosis or being treated for active tuberculosis
Item
Subject with active tuberculosis or being treated for active tuberculosis.
boolean
C0151332 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0151332 (UMLS CUI [2,2])
previous malignancy other than successfully treated nonmelanomatous skin cancer
Item
Known history of malignancy within the past 5 years with the exception of successfully treated squamous cell or basal cell cancer of the skin
boolean
C0006826 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1518408 (UMLS CUI [2,2])
C0007114 (UMLS CUI [2,3])
C0580352 (UMLS CUI [2,4])
C1272703 (UMLS CUI [2,5])
arterial blood pH and serum bicarbonate before infusion
Item
Arterial blood pH less than 7.1 or serum HCO3- <15 before infusion is started
boolean
C0428199 (UMLS CUI [1,1])
C0585032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
C0202059 (UMLS CUI [2,1])
C0585032 (UMLS CUI [2,2])
C0574032 (UMLS CUI [2,3])
Persistent cardiovascular instability requiring vasopressors
Item
Persistent cardiovascular instability requiring therapy with more than one vasopressor
boolean
C0205322 (UMLS CUI [1,1])
C0948268 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0042397 (UMLS CUI [2,2])
C0449788 (UMLS CUI [2,3])
participation could jeopardize subject's health or integrity of study
Item
A patient will be excluded if in the judgement of the Principle Investigator or GSK medical monitor their participation could jeopardize the health of the subject or the integrity of the study.
boolean
C2348568 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0018684 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C1947912 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])