Study centre number
Item
Site #
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
patient ID
Item
Patient #
integer
C2348585 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
1. Is patient male or female, from birth (minimum corrected gestational age of 37 weeks) to 16 years of age, inclusive at enrollment?
text
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Code List
1. Is patient male or female, from birth (minimum corrected gestational age of 37 weeks) to 16 years of age, inclusive at enrollment?
Item
2. Does patient: (please check ‘yes’ for at least one and complete appropriate sections on HIT History Form) a) Have documented heparin-induced thrombocytopenia (HIT), defined as a fall in platelet count to less than 100,000/μL or a >50 percent decrease in platelets after the initiation of heparin with no apparent explanation except HIT?
text
C0272285 (UMLS CUI [1,1])
C1301725 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0332282 (UMLS CUI [2,3])
C0019134 (UMLS CUI [2,4])
C0032181 (UMLS CUI [3,1])
C0547047 (UMLS CUI [3,2])
C1298908 (UMLS CUI [3,3])
C0681841 (UMLS CUI [3,4])
C1523987 (UMLS CUI [3,5])
Code List
2. Does patient: (please check ‘yes’ for at least one and complete appropriate sections on HIT History Form) a) Have documented heparin-induced thrombocytopenia (HIT), defined as a fall in platelet count to less than 100,000/μL or a >50 percent decrease in platelets after the initiation of heparin with no apparent explanation except HIT?
Item
b) Require anticoagulation with documented history of positive HIT test in the absence of current thrombocytopenia (i.e., patients at risk for HIT)?
text
C0003281 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1319556 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0040034 (UMLS CUI [3,1])
C0521116 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Code List
b) Require anticoagulation with documented history of positive HIT test in the absence of current thrombocytopenia (i.e., patients at risk for HIT)?
Item
c) Require alternative anticoagulation due to a suspicion of HIT (e.g., previous heparin exposure, in the absence of current platelet count or HIT antibody data)?
text
C0003281 (UMLS CUI [1,1])
C1523987 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0272285 (UMLS CUI [2,1])
C0332147 (UMLS CUI [2,2])
C0019134 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0332157 (UMLS CUI [3,3])
C0032181 (UMLS CUI [4,1])
C0521116 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1546437 (UMLS CUI [5,1])
C0744812 (UMLS CUI [5,2])
Code List
c) Require alternative anticoagulation due to a suspicion of HIT (e.g., previous heparin exposure, in the absence of current platelet count or HIT antibody data)?
Item
d) Require alternative anticoagulation due to an underlying condition such as AT-III deficiency or heparin resistance?
text
C0003281 (UMLS CUI [1,1])
C1523987 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0272375 (UMLS CUI [2])
C1167838 (UMLS CUI [3])
Code List
d) Require alternative anticoagulation due to an underlying condition such as AT-III deficiency or heparin resistance?
Item
3. Has the patient, if age appropriate, and the patient’s parent or guardian signed a (written) informed consent or assent prior to admission to the study?
text
C0021430 (UMLS CUI [1])
C5205794 (UMLS CUI [2])
Code List
3. Has the patient, if age appropriate, and the patient’s parent or guardian signed a (written) informed consent or assent prior to admission to the study?
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
1. Does the patient have any condition which, in the investigator’s opinion, would contraindicate the use of Argatroban or would endanger the patient if he/she participated in this trial?
text
C0048470 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Code List
1. Does the patient have any condition which, in the investigator’s opinion, would contraindicate the use of Argatroban or would endanger the patient if he/she participated in this trial?
Item
2. Did the patient have an unexplained aPTT >2 times the upper limit of normal at baseline in the absence of heparin?
text
C0030605 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C4288071 (UMLS CUI [1,3])
C0019134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Code List
2. Did the patient have an unexplained aPTT >2 times the upper limit of normal at baseline in the absence of heparin?
Item
3. Does the patient have any documented bleeding diathesis?
text
C0005779 (UMLS CUI [1])
Code List
3. Does the patient have any documented bleeding diathesis?
Item
4. Does the patient have an International Normalized Ratio (INR) >1.6 at baseline in the absence of Warfarin?
text
C0525032 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0043031 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Code List
4. Does the patient have an International Normalized Ratio (INR) >1.6 at baseline in the absence of Warfarin?
Item
5. If the patient has a known clinical site of bleeding or predisposition to bleeding (e.g., GI bleed, hematuria, hemorrhagic CVA, retroperitoneal hematoma, diabetic retinopathy, hemorrhagic pericardial effusion, or hemorrhagic pleural effusion), does the investigator deem the potential bleeding risk to outweigh the risk of continued thrombosis?
text
C3258161 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
C0018965 (UMLS CUI [4])
C0553692 (UMLS CUI [5])
C0341512 (UMLS CUI [6])
C0011884 (UMLS CUI [7])
C3670880 (UMLS CUI [8])
C0585110 (UMLS CUI [9])
C3251812 (UMLS CUI [10,1])
C0439093 (UMLS CUI [10,2])
C0040053 (UMLS CUI [10,3])
C0035647 (UMLS CUI [10,4])
Code List
5. If the patient has a known clinical site of bleeding or predisposition to bleeding (e.g., GI bleed, hematuria, hemorrhagic CVA, retroperitoneal hematoma, diabetic retinopathy, hemorrhagic pericardial effusion, or hemorrhagic pleural effusion), does the investigator deem the potential bleeding risk to outweigh the risk of continued thrombosis?
Item
6. Has the patient received any investigational medication within the 30 days prior to the first dose of study medication or is the patient scheduled to receive an investigational drug other than Argatroban during the course of the study?
text
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C2347804 (UMLS CUI [2,5])
Code List
6. Has the patient received any investigational medication within the 30 days prior to the first dose of study medication or is the patient scheduled to receive an investigational drug other than Argatroban during the course of the study?
Item
7. Does the patient have a known hypersensitivity to Argatroban or chemically related compounds?
text
C0048470 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Code List
7. Does the patient have a known hypersensitivity to Argatroban or chemically related compounds?
Item
8. Is the patient a female of childbearing potential who is pregnant (positive serum βHCG), breast feeding, or sexually active and not taking adequate contraceptive precautions (e.g. IUD or oral contraceptives)?
text
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0430060 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0006147 (UMLS CUI [5])
C0241028 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0205412 (UMLS CUI [6,3])
C0021900 (UMLS CUI [7])
C0009905 (UMLS CUI [8])
Code List
8. Is the patient a female of childbearing potential who is pregnant (positive serum βHCG), breast feeding, or sexually active and not taking adequate contraceptive precautions (e.g. IUD or oral contraceptives)?
Item
9. Is the patient receiving a thrombolytic medication (e.g. tPA)?
text
C0040044 (UMLS CUI [1])
C0032143 (UMLS CUI [2])
Code List
9. Is the patient receiving a thrombolytic medication (e.g. tPA)?
Item
10. Is the patient a neonate with a corrected gestational age of <44 weeks and bleeding in the head (Grade I or above) as determined by a head ultrasound?
text
C0021289 (UMLS CUI [1])
C3831006 (UMLS CUI [2])
C0018670 (UMLS CUI [3,1])
C0019080 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
Code List
10. Is the patient a neonate with a corrected gestational age of <44 weeks and bleeding in the head (Grade I or above) as determined by a head ultrasound?