ID

41367

Description

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The Eligibility Criteria Form has to be filled in at the screening visit. It determines the eligibility of the subject to participate in the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00039858

Keywords

Versions (1)
  1. 9/14/20 9/14/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 14, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Description

Study centre number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient #
Description

patient ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Visit Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1]
C1320303
1. Is patient male or female, from birth (minimum corrected gestational age of 37 weeks) to 16 years of age, inclusive at enrollment?
Description

Gender and age

Data type

text

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
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?
Description

Complete appropriate sections on HIT History Form.

Data type

text

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C1301725
UMLS CUI [2,1]
C0032181
UMLS CUI [2,2]
C0547047
UMLS CUI [2,3]
C0332282
UMLS CUI [2,4]
C0019134
UMLS CUI [3,1]
C0032181
UMLS CUI [3,2]
C0547047
UMLS CUI [3,3]
C1298908
UMLS CUI [3,4]
C0681841
UMLS CUI [3,5]
C1523987
b) Require anticoagulation with documented history of positive HIT test in the absence of current thrombocytopenia (i.e., patients at risk for HIT)?
Description

Anticoagulation required | positive HIT test | current thrombocytopenia absent

Data type

text

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C1319556
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0040034
UMLS CUI [3,2]
C0521116
UMLS CUI [3,3]
C0332197
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)?
Description

Alternative anticoagulation required | suspected diagnosis of HIT | previous heparin exposure | absence of current platelet count | absence of HIT antibody data

Data type

text

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1523987
UMLS CUI [1,3]
C1514873
UMLS CUI [2,1]
C0272285
UMLS CUI [2,2]
C0332147
UMLS CUI [3,1]
C0019134
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0332157
UMLS CUI [4,1]
C0032181
UMLS CUI [4,2]
C0521116
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C1546437
UMLS CUI [5,2]
C0744812
d) Require alternative anticoagulation due to an underlying condition such as AT-III deficiency or heparin resistance?
Description

Alternative anticoagulation required | AT-III deficiency | heparin resistance

Data type

text

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1523987
UMLS CUI [1,3]
C1514873
UMLS CUI [2]
C0272375
UMLS CUI [3]
C1167838
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?
Description

Informed consent | Informed assent

Data type

text

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C5205794
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Visit Date
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1]
C1320303
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?
Description

Argatroban contraincidation | trial participation dangerous to subject due to medical condition

Data type

text

Alias
UMLS CUI [1,1]
C0048470
UMLS CUI [1,2]
C1301624
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [2,4]
C2348568
2. Did the patient have an unexplained aPTT >2 times the upper limit of normal at baseline in the absence of heparin?
Description

Unexplained increase of aPPT value | absence of heparin

Data type

text

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C4288071
UMLS CUI [2,1]
C0019134
UMLS CUI [2,2]
C0332197
3. Does the patient have any documented bleeding diathesis?
Description

bleeding diathesis

Data type

text

Alias
UMLS CUI [1]
C0005779
4. Does the patient have an International Normalized Ratio (INR) >1.6 at baseline in the absence of Warfarin?
Description

INR increased | absence of warfarin therapy

Data type

text

Alias
UMLS CUI [1,1]
C0525032
UMLS CUI [1,2]
C0205217
UMLS CUI [2,1]
C0043031
UMLS CUI [2,2]
C0332197
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?
Description

Known site of bleeding | bleeding tendency | GI bleeding | hematuria | hemorragic CVA | retroperitoneal hematoma | diabetic retinopathy | hemorrhagic pericardial effusion | hemorrhagic pleural effusion | bleeding risk greater than thrombosis risk

Data type

text

Alias
UMLS CUI [1]
C3258161
UMLS CUI [2]
C1458140
UMLS CUI [3]
C0017181
UMLS CUI [4]
C0018965
UMLS CUI [5]
C0553692
UMLS CUI [6]
C0341512
UMLS CUI [7]
C0011884
UMLS CUI [8]
C3670880
UMLS CUI [9]
C0585110
UMLS CUI [10,1]
C3251812
UMLS CUI [10,2]
C0439093
UMLS CUI [10,3]
C0040053
UMLS CUI [10,4]
C0035647
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?
Description

Recent use of investigational medication | Other investigational drug planned during study period

Data type

text

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C1301732
UMLS CUI [2,4]
C0347984
UMLS CUI [2,5]
C2347804
7. Does the patient have a known hypersensitivity to Argatroban or chemically related compounds?
Description

Hypersensitivity to Argatroban

Data type

text

Alias
UMLS CUI [1,1]
C0048470
UMLS CUI [1,2]
C0020517
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)?
Description

Gender | childbearing potential | pregnancy | serum beta-HCG positive | breastfeeding | sexually active, contraception inadequate | IUD | oral contraceptives

Data type

text

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0032961
UMLS CUI [4,1]
C0430060
UMLS CUI [4,2]
C1514241
UMLS CUI [5]
C0006147
UMLS CUI [6,1]
C0241028
UMLS CUI [6,2]
C0700589
UMLS CUI [6,3]
C0205412
UMLS CUI [7]
C0021900
UMLS CUI [8]
C0009905
9. Is the patient receiving a thrombolytic medication (e.g. tPA)?
Description

Thrombolytic medication | tPA

Data type

text

Alias
UMLS CUI [1]
C0040044
UMLS CUI [2]
C0032143
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?
Description

Neonate | corrected gestational age | bleeding in head on untrasonography

Data type

text

Alias
UMLS CUI [1]
C0021289
UMLS CUI [2]
C3831006
UMLS CUI [3,1]
C0018670
UMLS CUI [3,2]
C0019080
UMLS CUI [3,3]
C0041618
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
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])
Item Group
Inclusion Criteria
C1512693 (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])
Gender and age
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?
CL Item
Yes (Yes)
CL Item
No (No)
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])
HIT platelet count
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?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
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])
HIT platelet count
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)?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
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])
HIT platelet count
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)?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
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])
HIT platelet count
Code List
d) Require alternative anticoagulation due to an underlying condition such as AT-III deficiency or heparin resistance?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
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])
Gender and age
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?
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
Gender and age
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?
CL Item
Yes (Yes)
CL Item
No (No)
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])
Gender and age
Code List
2. Did the patient have an unexplained aPTT >2 times the upper limit of normal at baseline in the absence of heparin?
CL Item
Yes (Yes)
CL Item
No (No)
Item
3. Does the patient have any documented bleeding diathesis?
text
C0005779 (UMLS CUI [1])
Gender and age
Code List
3. Does the patient have any documented bleeding diathesis?
CL Item
Yes (Yes)
CL Item
No (No)
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])
Gender and age
Code List
4. Does the patient have an International Normalized Ratio (INR) >1.6 at baseline in the absence of Warfarin?
CL Item
Yes (Yes)
CL Item
No (No)
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])
HIT platelet count
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?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
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])
Gender and age
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?
CL Item
Yes (Yes)
CL Item
No (No)
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])
Gender and age
Code List
7. Does the patient have a known hypersensitivity to Argatroban or chemically related compounds?
CL Item
Yes (Yes)
CL Item
No (No)
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])
Gender and age
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)?
CL Item
Yes (Yes)
CL Item
No (No)
Item
9. Is the patient receiving a thrombolytic medication (e.g. tPA)?
text
C0040044 (UMLS CUI [1])
C0032143 (UMLS CUI [2])
Gender and age
Code List
9. Is the patient receiving a thrombolytic medication (e.g. tPA)?
CL Item
Yes (Yes)
CL Item
No (No)
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])
Gender and age
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?
CL Item
Yes (Yes)
CL Item
No (No)
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