ID

41370

Descrição

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 HIT History Form has to be filled in at the screening visit. It is used to record details of prior Heparin Induced Thrombocytopaenia. To be completed within 7 days before treatment initiation.

Link

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

Palavras-chave

Versões (1)
  1. 14/09/2020 14/09/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

14 de setembro de 2020

DOI

Para um pedido faça login.

Licença

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

Inglês

HIT History

1 Formulários  
  1. StudyEvent: ODM
    1. HIT History
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Descrição

Study centre number

Tipo de dados

integer

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

patient ID

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrição

visit date

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Descrição

Investigator Name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
If ‘YES’ was answered for Inclusion Criterion 2a, please give details of the HIT diagnosis and heparin exposure as follows:
Descrição

If ‘YES’ was answered for Inclusion Criterion 2a, please give details of the HIT diagnosis and heparin exposure as follows:

Alias
UMLS CUI-1
C0272285
UMLS CUI-2
C0332157
UMLS CUI-3
C0019134
Date of Diagnosis:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1]
C2316983
Platelet Count drop (after initiation of heparin):
Descrição

Platelet Count decrease after heparin initiation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392386
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1704686
UMLS CUI [1,4]
C0019134
Was there an associated thrombosis?
Descrição

Thrombosis associated with HIT

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040053
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0272285
Was a confirmatory diagnostic HIT test completed?
Descrição

*If ‘Yes’, indicate test, date completed, and results: (Check all that apply; note enrollment is not contingent on receipt of results. Complete this form when results are available.)

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0750484
HPF4 ELISA
Descrição

HPF4 ELISA

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4512079
UMLS CUI [1,2]
C0014441
HPF4 ELISA - Date:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C4512079
UMLS CUI [1,2]
C0014441
UMLS CUI [1,3]
C0011008
HPF4 ELISA - Result:
Descrição

HPF4 ELISA Result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C4512079
UMLS CUI [1,2]
C0014441
UMLS CUI [1,3]
C0456984
SRA
Descrição

SRA

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3506382
SRA - Date:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3506382
UMLS CUI [1,2]
C0011008
SRA - Result:
Descrição

SRA Result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3506382
UMLS CUI [1,2]
C0456984
HIPA
Descrição

HIPA

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0919798
HIPA - Date:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0919798
UMLS CUI [1,2]
C0011008
HIPA - Result:
Descrição

HIPA Result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0919798
UMLS CUI [1,2]
C0456984
Confirmatory diagnostic HIT test, other
Descrição

HIT confirmatory diagnostic test, other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0750484
UMLS CUI [1,4]
C0205394
HIT confirmatory diagnostic test - Other (specify)
Descrição

HIT confirmatory diagnostic test, other, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0750484
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C1521902
HIT confirmatory diagnostic test, other - Date:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0750484
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C0011008
HIT confirmatory diagnostic test, other - Result:
Descrição

HIT confirmatory diagnostic test, other, result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0750484
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C0456984
If ‘YES’ was answered for Inclusion Criterion 2b, please give details of the most recent positive HIT test history and prior heparin exposure as follows:
Descrição

If ‘YES’ was answered for Inclusion Criterion 2b, please give details of the most recent positive HIT test history and prior heparin exposure as follows:

Alias
UMLS CUI-1
C1513491
UMLS CUI-2
C0272285
UMLS CUI-3
C0456984
Date of Positive HIT Diagnosis:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0272285
UMLS CUI [1,3]
C0011008
HPF4 ELISA
Descrição

Which HIT test was done? (Check all that apply, enter date and results; note enrollment is not contingent on receipt of results.)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4512079
UMLS CUI [1,2]
C0014441
HPF4 ELISA - Date:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C4512079
UMLS CUI [1,2]
C0014441
UMLS CUI [1,3]
C0011008
HPF4 ELISA - Result:
Descrição

HPF4 ELISA Result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C4512079
UMLS CUI [1,2]
C0014441
UMLS CUI [1,3]
C0456984
SRA
Descrição

SRA

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3506382
SRA - Date:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C3506382
UMLS CUI [1,2]
C0011008
SRA - Result:
Descrição

SRA Result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3506382
UMLS CUI [1,2]
C0456984
HIPA
Descrição

HIPA

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0919798
HIPA - Date:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0919798
UMLS CUI [1,2]
C0011008
HIPA - Result:
Descrição

HIPA Result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0919798
UMLS CUI [1,2]
C0456984
Confirmatory diagnostic HIT test, other
Descrição

HIT confirmatory diagnostic test, other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0750484
UMLS CUI [1,4]
C0205394
HIT confirmatory diagnostic test - Other (specify)
Descrição

HIT confirmatory diagnostic test, other, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0750484
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C1521902
HIT confirmatory diagnostic test, other - Date:
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0750484
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C0011008
HIT confirmatory diagnostic test, other - Result:
Descrição

HIT confirmatory diagnostic test, other, result

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0272285
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0750484
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C0456984
Was there an associated platelet count drop (after initiation of heparin)?
Descrição

Platelet Count decrease after heparin initiation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392386
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1704686
UMLS CUI [1,4]
C0019134
*If Yes, did the platelet count drop: To less than 100,000/μL
Descrição

Platelet count drop

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392386
*If Yes, did the platelet count drop: ≥50 percent from baseline
Descrição

Platelet count drop

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392386
*If Yes, did the platelet count drop: Neither of the above
Descrição

Platelet count drop

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392386
Was there an associated thrombosis?
Descrição

Thrombosis associated with HIT

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0040053
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0272285
Previous heparin exposure data unavailable or unknown
Descrição

Please fill in the Heparin Exposure section unless YES ticked.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0019134
UMLS CUI [1,3]
C1511726
UMLS CUI [1,4]
C0439673
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0019134
UMLS CUI [2,3]
C1511726
UMLS CUI [2,4]
C0686905
If ‘YES’ was answered for Inclusion Criterion 2c, please provide details of all previous heparin exposure/data:
Descrição

If ‘YES’ was answered for Inclusion Criterion 2c, please provide details of all previous heparin exposure/data:

Alias
UMLS CUI-1
C0205156
UMLS CUI-2
C0332157
UMLS CUI-3
C0019134
UMLS CUI-4
C0205197
Previous heparin exposure data unavailable or unknown
Descrição

Please fill in the Heparin Exposure section unless YES ticked.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0019134
UMLS CUI [1,3]
C1511726
UMLS CUI [1,4]
C0439673
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0019134
UMLS CUI [2,3]
C1511726
UMLS CUI [2,4]
C0686905
If ‘YES’ was answered for Inclusion Criterion 2d, what was the underlying condition?
Descrição

If ‘YES’ was answered for Inclusion Criterion 2d, what was the underlying condition?

Alias
UMLS CUI-1
C0272375
UMLS CUI-2
C4722602
UMLS CUI-3
C0348080
If ‘YES’ was answered for Inclusion Criterion 2d, what was the underlying condition?
Descrição

Underlying condition of antithrombin III deficiency

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0272375
UMLS CUI [1,2]
C4722602
UMLS CUI [1,3]
C0348080
Other - Specify:
Descrição

Alternative anticoagulation required | Other underlying disease, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1523987
UMLS CUI [1,3]
C1514873
UMLS CUI [2,1]
C4722602
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C1521902
Heparin Exposure
Descrição

Heparin Exposure

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0019134
Criterion
Descrição

Please select to which criterion is the following data related. If one entry is related to multiple criteria, please fill in multiple times to include all of them.

Tipo de dados

text

Alias
UMLS CUI [1]
C1512693
Type of Heparin
Descrição

Type of heparin

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0332307
Comments
Descrição

Types of heparin - Comments

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0947611
Start Date
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0808070
Stop Date
Descrição

(dd-mmm-yyyy)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0806020
Route
Descrição

Route of heparin admission

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0013153
Route - Other, specify;
Descrição

Route of heparin admission - other, specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1521902
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HIT History

1 Formulários
  1. StudyEvent: ODM
    1. HIT History
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
If ‘YES’ was answered for Inclusion Criterion 2a, please give details of the HIT diagnosis and heparin exposure as follows:
C0272285 (UMLS CUI-1)
C0332157 (UMLS CUI-2)
C0019134 (UMLS CUI-3)
Date of Diagnosis
Item
Date of Diagnosis:
date
C2316983 (UMLS CUI [1])
Item
Platelet Count drop (after initiation of heparin):
text
C0392386 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0019134 (UMLS CUI [1,4])
Platelet Count decrease after heparin initiation
Code List
Platelet Count drop (after initiation of heparin):
CL Item
To less than 100,000/μl (To less than 100,000/μl)
CL Item
≥50 percent decrease from baseline (≥50 percent decrease from baseline)
Thrombosis associated with HIT
Item
Was there an associated thrombosis?
boolean
C0040053 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0272285 (UMLS CUI [1,3])
Item
Was a confirmatory diagnostic HIT test completed?
text
C0272285 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
HIT confirmatory diagnostic test
Code List
Was a confirmatory diagnostic HIT test completed?
CL Item
Yes* (Yes*)
CL Item
No (No)
HPF4 ELISA
Item
HPF4 ELISA
boolean
C4512079 (UMLS CUI [1,1])
C0014441 (UMLS CUI [1,2])
HPF4 ELISA Date
Item
HPF4 ELISA - Date:
date
C4512079 (UMLS CUI [1,1])
C0014441 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
HPF4 ELISA - Result:
text
C4512079 (UMLS CUI [1,1])
C0014441 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
HPF4 ELISA Result
Code List
HPF4 ELISA - Result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
SRA
Item
SRA
boolean
C3506382 (UMLS CUI [1])
SRA Date
Item
SRA - Date:
date
C3506382 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
SRA - Result:
text
C3506382 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
HPF4 ELISA Result
Code List
SRA - Result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
HIPA
Item
HIPA
boolean
C0919798 (UMLS CUI [1])
HIPA Date
Item
HIPA - Date:
date
C0919798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
HIPA - Result:
text
C0919798 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
HPF4 ELISA Result
Code List
HIPA - Result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
HIT confirmatory diagnostic test, other
Item
Confirmatory diagnostic HIT test, other
boolean
C0272285 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
HIT confirmatory diagnostic test, other, specify
Item
HIT confirmatory diagnostic test - Other (specify)
text
C0272285 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
HIT confirmatory diagnostic test, other, date
Item
HIT confirmatory diagnostic test, other - Date:
date
C0272285 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Item
HIT confirmatory diagnostic test, other - Result:
text
C0272285 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,5])
HPF4 ELISA Result
Code List
HIT confirmatory diagnostic test, other - Result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
If ‘YES’ was answered for Inclusion Criterion 2b, please give details of the most recent positive HIT test history and prior heparin exposure as follows:
C1513491 (UMLS CUI-1)
C0272285 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Date of HIT Diagnosis
Item
Date of Positive HIT Diagnosis:
date
C0430022 (UMLS CUI [1,1])
C0272285 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
HPF4 ELISA
Item
HPF4 ELISA
boolean
C4512079 (UMLS CUI [1,1])
C0014441 (UMLS CUI [1,2])
HPF4 ELISA Date
Item
HPF4 ELISA - Date:
date
C4512079 (UMLS CUI [1,1])
C0014441 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
HPF4 ELISA - Result:
text
C4512079 (UMLS CUI [1,1])
C0014441 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
HPF4 ELISA Result
Code List
HPF4 ELISA - Result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
SRA
Item
SRA
boolean
C3506382 (UMLS CUI [1])
SRA Date
Item
SRA - Date:
date
C3506382 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
SRA - Result:
text
C3506382 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
HPF4 ELISA Result
Code List
SRA - Result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
HIPA
Item
HIPA
boolean
C0919798 (UMLS CUI [1])
HIPA Date
Item
HIPA - Date:
date
C0919798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
HIPA - Result:
text
C0919798 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
HPF4 ELISA Result
Code List
HIPA - Result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
HIT confirmatory diagnostic test, other
Item
Confirmatory diagnostic HIT test, other
boolean
C0272285 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
HIT confirmatory diagnostic test, other, specify
Item
HIT confirmatory diagnostic test - Other (specify)
text
C0272285 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
HIT confirmatory diagnostic test, other, date
Item
HIT confirmatory diagnostic test, other - Date:
date
C0272285 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Item
HIT confirmatory diagnostic test, other - Result:
text
C0272285 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,5])
HPF4 ELISA Result
Code List
HIT confirmatory diagnostic test, other - Result:
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Was there an associated platelet count drop (after initiation of heparin)?
text
C0392386 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0019134 (UMLS CUI [1,4])
HIT confirmatory diagnostic test
Code List
Was there an associated platelet count drop (after initiation of heparin)?
CL Item
Yes* (Yes*)
CL Item
No (No)
Platelet count drop
Item
*If Yes, did the platelet count drop: To less than 100,000/μL
boolean
C0392386 (UMLS CUI [1])
Platelet count drop
Item
*If Yes, did the platelet count drop: ≥50 percent from baseline
boolean
C0392386 (UMLS CUI [1])
Platelet count drop
Item
*If Yes, did the platelet count drop: Neither of the above
boolean
C0392386 (UMLS CUI [1])
Thrombosis associated with HIT
Item
Was there an associated thrombosis?
boolean
C0040053 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0272285 (UMLS CUI [1,3])
Heparin exposure data unknown or unavailable
Item
Previous heparin exposure data unavailable or unknown
boolean
C0332157 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
C0332157 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1511726 (UMLS CUI [2,3])
C0686905 (UMLS CUI [2,4])
Item Group
If ‘YES’ was answered for Inclusion Criterion 2c, please provide details of all previous heparin exposure/data:
C0205156 (UMLS CUI-1)
C0332157 (UMLS CUI-2)
C0019134 (UMLS CUI-3)
C0205197 (UMLS CUI-4)
Heparin exposure data unknown or unavailable
Item
Previous heparin exposure data unavailable or unknown
boolean
C0332157 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
C0332157 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1511726 (UMLS CUI [2,3])
C0686905 (UMLS CUI [2,4])
Item Group
If ‘YES’ was answered for Inclusion Criterion 2d, what was the underlying condition?
C0272375 (UMLS CUI-1)
C4722602 (UMLS CUI-2)
C0348080 (UMLS CUI-3)
Item
If ‘YES’ was answered for Inclusion Criterion 2d, what was the underlying condition?
text
C0272375 (UMLS CUI [1,1])
C4722602 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,3])
Inclusion Criterion 2d
Code List
If ‘YES’ was answered for Inclusion Criterion 2d, what was the underlying condition?
CL Item
AT-III deficiency (AT-III deficiency)
CL Item
Heparin resistance (Heparin resistance)
CL Item
Other, specify: (Other, specify:)
Alternative anticoagulation required | Other underlying disease, specify
Item
Other - Specify:
text
C0003281 (UMLS CUI [1,1])
C1523987 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C4722602 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C1521902 (UMLS CUI [2,4])
Item Group
Heparin Exposure
C0332157 (UMLS CUI-1)
C0019134 (UMLS CUI-2)
Item
Criterion
text
C1512693 (UMLS CUI [1])
Inclusion criterion
Code List
Criterion
CL Item
2a (2a)
CL Item
2b (2b)
CL Item
2c (2c)
Item
Type of Heparin
text
C0019134 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Heparin
Code List
Type of Heparin
CL Item
Low molecular weight heparin (1)
CL Item
Porcine unfractionated heparin (2)
CL Item
Bovine unfractionated heparin (3)
CL Item
Unspecified unfractionated heparin (4)
CL Item
Other (specify in Comments) (*5)
Types of heparin - Comments
Item
Comments
text
C0019134 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Start date of heparin
Item
Start Date
date
C0019134 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date of heparin
Item
Stop Date
date
C0019134 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Route
text
C0019134 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Route of heparin admission
Code List
Route
CL Item
IV infusion (IV infusion)
CL Item
IV flush (IV flush)
CL Item
SQ (SQ)
CL Item
Other (specify) (Other (specify))
Route of heparin admission - other, specify
Item
Route - Other, specify;
text
C0019134 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
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