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37367

Beschreibung

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form contains the Eligibility Criteria the participant has to meet, and is to be filled in at Screening.

Link

https://clinicaltrials.gov/ct2/show/NCT00996840

Stichworte

Versionen (1)
  1. 20.07.19 20.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Juli 2019

DOI

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Creative Commons BY-NC 3.0
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    SB-681323 in ALI/ARDS risk patients - NCT00996840

    Englisch

    Eligibility Criteria

    1 Formulare  
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschreibung

    Subject Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date/Time of Assessment
    Beschreibung

    Date/Time of Assessment

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C1516048
    UMLS CUI [1,2]
    C1264639
    Eligibility Criteria
    Beschreibung

    Eligibility Criteria

    Alias
    UMLS CUI-1
    C1516637
    Did the subject meet all the entry criteria?
    Beschreibung

    If no, please select all boxes corresponding to violations of any inclusion/exclusion criteria

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1516637
    UMLS CUI [1,2]
    C1550543
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Male or female, 18 - 80 years of age (inclusive)
    Beschreibung

    Gender and Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    Patients with major trauma admitted to the emergency department, ICU, step-down, or equivalent unit
    Beschreibung

    major trauma and admitted to emergency department, ICU, step-down or equivalent unit

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205404
    UMLS CUI [1,2]
    C3714660
    UMLS CUI [2]
    C0583239
    UMLS CUI [3]
    C0583237
    UMLS CUI [4,1]
    C1627345
    UMLS CUI [4,2]
    C0030673
    UMLS CUI [5,1]
    C0030673
    UMLS CUI [5,2]
    C0205163
    UMLS CUI [5,3]
    C0019988
    Injury Severity score (ISS) >=16 to <70
    Beschreibung

    Injury Severity score

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021504
    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).
    Beschreibung

    Female subjects must agree to use contraception until one week post-last dose, if applicable.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0700589
    UMLS CUI [2,2]
    C0449238
    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
    Beschreibung

    Male contraception

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0086580
    UMLS CUI [1,2]
    C0449238
    BMI within the range 19.0 - 40.0 kg/m2 inclusive
    Beschreibung

    clinical estimate of height and weight is acceptable

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    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
    Beschreibung

    Informed Consent and Compliance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0525058
    QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
    Beschreibung

    QTcB or QTcF time or QTC in subjects with Bundle Branch Block

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1882513
    UMLS CUI [2]
    C1882512
    UMLS CUI [3,1]
    C0489625
    UMLS CUI [3,2]
    C0006384
    The subject must be randomized into the study within 24-26 hours from the time of trauma.
    Beschreibung

    Time between trauma and randomization

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1272706
    UMLS CUI [1,2]
    C3714660
    UMLS CUI [1,3]
    C0034656
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Known positive Hepatitis B surface antigen or Hepatitis C antibody.
    Beschreibung

    Known HbsAg or HCV antibody

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205309
    UMLS CUI [1,2]
    C0149709
    UMLS CUI [2,1]
    C0205309
    UMLS CUI [2,2]
    C0281863
    Known positive test for HIV antibody
    Beschreibung

    Known positive HIV antibody

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0920548
    UMLS CUI [1,2]
    C0205309
    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.
    Beschreibung

    Recent history of substance abuse or alcohol abuse causing liver disease such as cirrhosis, chronic ascites or portal hypertension, or recent withdrawal syndrome

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C0085762
    UMLS CUI [1,3]
    C0678227
    UMLS CUI [1,4]
    C0341439
    UMLS CUI [2,1]
    C0332185
    UMLS CUI [2,2]
    C0038586
    UMLS CUI [2,3]
    C0678227
    UMLS CUI [2,4]
    C0341439
    UMLS CUI [3,1]
    C0332185
    UMLS CUI [3,2]
    C0085762
    UMLS CUI [3,3]
    C0678227
    UMLS CUI [3,4]
    C0023890
    UMLS CUI [4,1]
    C0332185
    UMLS CUI [4,2]
    C0038586
    UMLS CUI [4,3]
    C0678227
    UMLS CUI [4,4]
    C0023890
    UMLS CUI [5,1]
    C0332185
    UMLS CUI [5,2]
    C0085762
    UMLS CUI [5,3]
    C0678227
    UMLS CUI [5,4]
    C0008679
    UMLS CUI [5,5]
    C0003962
    UMLS CUI [6,1]
    C0332185
    UMLS CUI [6,2]
    C0038586
    UMLS CUI [6,3]
    C0678227
    UMLS CUI [6,4]
    C0008679
    UMLS CUI [6,5]
    C0003962
    UMLS CUI [7,1]
    C0332185
    UMLS CUI [7,2]
    C0085762
    UMLS CUI [7,3]
    C0678227
    UMLS CUI [7,4]
    C0020541
    UMLS CUI [8,1]
    C0332185
    UMLS CUI [8,2]
    C0038586
    UMLS CUI [8,3]
    C0678227
    UMLS CUI [8,4]
    C0020541
    UMLS CUI [9,1]
    C0332185
    UMLS CUI [9,2]
    C0038587
    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)
    Beschreibung

    Recent clinical trial participation with recent investigational product administration

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C2348568
    UMLS CUI [2,3]
    C0332185
    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
    Beschreibung

    Sensitivity to study medications or their components, or drug or other allergy contraindicating participation

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C1705248
    UMLS CUI [2,3]
    C0013230
    UMLS CUI [3,1]
    C0013182
    UMLS CUI [3,2]
    C1301624
    UMLS CUI [3,3]
    C2348568
    UMLS CUI [4,1]
    C0205394
    UMLS CUI [4,2]
    C0020517
    UMLS CUI [4,3]
    C1301624
    UMLS CUI [4,4]
    C2348568
    Hemoglobin < 7g/dL.
    Beschreibung

    Hemoglobin

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019046
    Pregnant females as determined by positive serum or urine hCG test prior to dosing
    Beschreibung

    Pregnancy (by serum or urine hCG test)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0430056
    UMLS CUI [3]
    C0430060
    Lactating females.
    Beschreibung

    Lactating females

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2828358
    Unwillingness or inability to follow the procedures outlined in the protocol
    Beschreibung

    Unwillingness or inability to follow protocol

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [2,1]
    C0525058
    UMLS CUI [2,2]
    C1299582
    History of sensitivity to heparin or heparin-induced thrombocytopenia
    Beschreibung

    sensitivity to heparin or heparin-induced thrombocytopenia

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0019134
    UMLS CUI [2]
    C0272285
    Diagnosis of ALI at admission
    Beschreibung

    ALI at admission

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0242488
    UMLS CUI [1,2]
    C0030673
    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
    Beschreibung

    Head trauma by AIS, uncontrolled intracranial hypertension by ICP, liver trauma by score, or trauma deemed unsurvivable

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0018674
    UMLS CUI [1,2]
    C0000722
    UMLS CUI [2,1]
    C0151740
    UMLS CUI [2,2]
    C0205269
    UMLS CUI [3]
    C0021880
    UMLS CUI [4,1]
    C0000722
    UMLS CUI [4,2]
    C0160390
    UMLS CUI [5,1]
    C0871010
    UMLS CUI [5,2]
    C3714660
    UMLS CUI [5,3]
    C3151529
    Known history of neuromuscular disease or cord injury at C5 or above
    Beschreibung

    Known history of neuromuscular disease or high cord injury

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205309
    UMLS CUI [1,2]
    C0027868
    UMLS CUI [2,1]
    C0037929
    UMLS CUI [2,2]
    C1515974
    Elevated ALT > 5x ULN
    Beschreibung

    ALT

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    History of bone marrow or solid organ transplant
    Beschreibung

    History of bone marrow or solid organ transplant

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0730400
    UMLS CUI [2]
    C0005961
    Known history of auto-immune disorder in which immunosuppressive agents, other than prednisone, were required within the last 6 weeks
    Beschreibung

    auto-immune disorder requiring recent immunosuppressive agents other than prednisone

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004364
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [1,3]
    C1555447
    UMLS CUI [1,4]
    C0021081
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0032952
    Known to be receiving oral or intravenous corticosteroids within 7 days of admission
    Beschreibung

    recent oral or intravenous corticosteroids

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0001617
    UMLS CUI [1,2]
    C0442027
    UMLS CUI [1,3]
    C0332185
    UMLS CUI [2,1]
    C0332185
    UMLS CUI [2,2]
    C0348016
    UMLS CUI [2,3]
    C0001617
    Subject with active tuberculosis or being treated for active tuberculosis.
    Beschreibung

    active tuberculosis or being treated for active tuberculosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0151332
    UMLS CUI [2,1]
    C0013216
    UMLS CUI [2,2]
    C0151332
    Known history of malignancy within the past 5 years with the exception of successfully treated squamous cell or basal cell cancer of the skin
    Beschreibung

    previous malignancy other than successfully treated nonmelanomatous skin cancer

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C1518408
    UMLS CUI [2,3]
    C0007114
    UMLS CUI [2,4]
    C0580352
    UMLS CUI [2,5]
    C1272703
    Arterial blood pH less than 7.1 or serum HCO3- <15 before infusion is started
    Beschreibung

    arterial blood pH and serum bicarbonate before infusion

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0428199
    UMLS CUI [1,2]
    C0585032
    UMLS CUI [1,3]
    C0574032
    UMLS CUI [2,1]
    C0202059
    UMLS CUI [2,2]
    C0585032
    UMLS CUI [2,3]
    C0574032
    Persistent cardiovascular instability requiring therapy with more than one vasopressor
    Beschreibung

    Persistent cardiovascular instability requiring vasopressors

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205322
    UMLS CUI [1,2]
    C0948268
    UMLS CUI [2,1]
    C3146298
    UMLS CUI [2,2]
    C0042397
    UMLS CUI [2,3]
    C0449788
    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.
    Beschreibung

    participation could jeopardize subject's health or integrity of study

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0035647
    UMLS CUI [1,3]
    C0018684
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C0035647
    UMLS CUI [2,3]
    C1947912
    UMLS CUI [2,4]
    C0008976
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    Eligibility Criteria

    1 Formulare
    1. StudyEvent: ODM
      1. Eligibility Criteria
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date/Time of Assessment
    Item
    Date/Time of Assessment
    datetime
    C1516048 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item Group
    Eligibility Criteria
    C1516637 (UMLS CUI-1)
    entry criteria
    Item
    Did the subject meet all the entry criteria?
    boolean
    C1516637 (UMLS CUI [1,1])
    C1550543 (UMLS CUI [1,2])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    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])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    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])
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