ID

32159

Beschreibung

Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

Stichworte

Versionen (1)
  1. 22.10.18 22.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22. Oktober 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619

Englisch

Visit 01

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 01
Details of Operation
Beschreibung

Details of Operation

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C1522508
Type of surgery
Beschreibung

Operative Surgical Procedures; Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332307
Cancer surgery
Beschreibung

Cancer surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0920424
Date and time of anesthesia induction
Beschreibung

Induction of general anesthesia; Date in time; Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0473960
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Time of incision
Beschreibung

Time of incision

Datentyp

time

Alias
UMLS CUI [1]
C2116297
Time of incision closure
Beschreibung

Time of incision; closure by suture

Datentyp

time

Alias
UMLS CUI [1,1]
C2116297
UMLS CUI [1,2]
C0009068
Type of Anesthesia
Beschreibung

Anesthesia type

Datentyp

text

Alias
UMLS CUI [1]
C1305863
Was any i.v. or central venous line used?
Beschreibung

Peripheral Venous Catheter; Central venous catheter, device

Datentyp

boolean

Alias
UMLS CUI [1]
C2985513
UMLS CUI [2]
C1145640
Was cell saver equipment used?
Beschreibung

Cell saver, Equipment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1441512
UMLS CUI [1,2]
C0014672
Date and time of removal of Indewelling Intrathecal or Epidural Catheter
Beschreibung

date time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C3524354
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [2,1]
C3524353
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Haematology
Beschreibung

Haematology

Alias
UMLS CUI-1
C0474523
Post-operative - Prior to first post-operative injection
Beschreibung

Hematology finding, post-operative care

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C2112579
Laboratory Name/City
Beschreibung

Hematology finding, Performing Laboratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1882331
Date and Time of Sampling
Beschreibung

Hematology finding; Sampling; Date in time; Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Test
Beschreibung

Hematology finding; Hematologic Tests

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0018941
Value
Beschreibung

Hematology finding; Numerical Value

Datentyp

float

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1522609
Unit
Beschreibung

Hematology finding; Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0439148
If other unit, specify
Beschreibung

Hematology finding; Unit, other

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C0205394
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Undergoing major abdominal surgery (any surgery between the diaphragm and the pelvic floor) lasting longer than 45 min (duration from induction of anesthesia to closure)
Beschreibung

major abdominal surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0455612
Over 40 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Active, clinically significant bleeding
Beschreibung

Bleeding active, Clinical significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0741554
UMLS CUI [1,2]
C2826293
Documented congenital or acquired bleeding tendency/disorder(s)
Beschreibung

Bleeding tendency, Blood coagulation disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0005779
Active ulcerative gastrointestinal disease unless it's the reason for the present surgery
Beschreibung

Gastrointestinal Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, orophthalmologic surgery
Beschreibung

Intracranial Hemorrhages, Recent; Operation on brain, Recent; Spinal Cord, Operative Surgical Procedures, Recent; Ophthalmologic Surgical Procedures, Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151699
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0195775
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0037925
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0038901
UMLS CUI [4,2]
C0332185
Indwelling intrathecal or epidural catheters for more than 2 hours after surgical closure
Beschreibung

Catheters, Spinal, Intrathecal

Datentyp

boolean

Alias
UMLS CUI [1]
C2584606
Patient with indwelling intrathecal or epidural catheter at the time of randomization, or patients who had a traumatic puncture or unusual difficulty in applying the catheter (e.g., more than two attempts or a bloody tap)
Beschreibung

Catheter, Spinal, Intrathecal; Function procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C2584606
UMLS CUI [2]
C0034117
Known cerebral metastases
Beschreibung

Cerebral metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0555278
Patient in whom hemostasis has not been established 6 hours after surgical closure
Beschreibung

Hemostatic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0019116
Current thrombocytopenia (<100.000/mm3)
Beschreibung

Thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0040034
Bacterial endocarditis
Beschreibung

Bacterial Endocarditis

Datentyp

boolean

Alias
UMLS CUI [1]
C0014121
Creatinine level above 2.0 mg/dl (180 μmol/L) in a well-hydrated patient
Beschreibung

Creatinine measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
Documented hypersensitivity to contrast media
Beschreibung

Contrast Media; Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0020517
Use of any contraindicated drug that could not be combined with the injection of contrast medium
Beschreibung

Contrast Media; Medical Contraindication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C1301624
Patient with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings
Beschreibung

Peripheral vascular disease; Peripheral ischemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0235490
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Undergoing major abdominal surgery (any surgery between the diaphragm and the pelvic floor) lasting longer than 45 min (duration from induction of anesthesia to closure)
Beschreibung

major abdominal surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0455612
Over 40 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Patient who has signed the informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Active, clinically significant bleeding
Beschreibung

Bleeding active, Clinical significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0741554
UMLS CUI [1,2]
C2826293
Documented congenital or acquired bleeding tendency/disorder(s)
Beschreibung

Bleeding tendency, Blood coagulation disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0005779
Active ulcerative gastrointestinal disease unless it's the reason for the present surgery
Beschreibung

Gastrointestinal Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, orophthalmologic surgery
Beschreibung

Intracranial Hemorrhages, Recent; Operation on brain, Recent; Spinal Cord, Operative Surgical Procedures, Recent; Ophthalmologic Surgical Procedures, Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151699
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0195775
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0037925
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0038901
UMLS CUI [4,2]
C0332185
Indwelling intrathecal or epidural catheters for more than 2 hours after surgical closure
Beschreibung

Catheters, Spinal, Intrathecal

Datentyp

boolean

Alias
UMLS CUI [1]
C2584606
Patient with indwelling intrathecal or epidural catheter at the time of randomization, or patients who had a traumatic puncture or unusual difficulty in applying the catheter (e.g., more than two attempts or a bloody tap)
Beschreibung

Catheter, Spinal, Intrathecal; Function procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C2584606
UMLS CUI [2]
C0034117
Known cerebral metastases
Beschreibung

Cerebral metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0555278
Patient in whom hemostasis has not been established 6 hours after surgical closure
Beschreibung

Hemostatic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0019116
Current thrombocytopenia (<100.000/mm3)
Beschreibung

Thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0040034
Bacterial endocarditis
Beschreibung

Bacterial Endocarditis

Datentyp

boolean

Alias
UMLS CUI [1]
C0014121
Creatinine level above 2.0 mg/dl (180 μmol/L) in a well-hydrated patient
Beschreibung

Creatinine measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
Documented hypersensitivity to contrast media
Beschreibung

Contrast Media; Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0020517
Known pregnancy and/or lactation
Beschreibung

Pregnancy; Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Use of any contraindicated drug that could not be combined with the injection of contrast medium
Beschreibung

Contrast Media; Medical Contraindication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C1301624
Patient with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings
Beschreibung

Peripheral vascular disease; Peripheral ischemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0235490
Mental disorders that could interfere with study participation and/or failure to give written informed consent to take part in the study
Beschreibung

Mental Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
Patient's life-expectancy < 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Clinical sign of DVT and/or history of recent DVT (i.e., within the previous 3 months)
Beschreibung

Deep Vein Thrombosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0149871
Participation in any other therapeutic drug study or a device study evaluating DVT prophylaxis within 90 days preceding inclusion
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Previous participation in a study of fondaparinux sodium
Beschreibung

Study Subject Participation Status; Fondaparinux sodium

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1098510
Known hypersensitivity to fondaparinux sodium and its excipients
Beschreibung

Fondaparinux, Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1098510
UMLS CUI [1,2]
C0020517
Current addictive disorders that could interfere with study participation
Beschreibung

Mental disorders, Addictive behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0085281
Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking GPIIb-IIIa platelet receptors two calendar days before surgery
Beschreibung

Use of anticoagulation; preoperative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449867
UMLS CUI [1,2]
C0445204
Patients for whom anticoagulant therapy was contraindicated or who have, due to concomitant disease, an indication for oral anticoagulant or heparins (including LMWH) and who can not discontinue those treatments
Beschreibung

Anticoagulation contraindicated; Use of anticoagulation, no, Discontinuation (procedure)

Datentyp

boolean

Alias
UMLS CUI [1]
C1531588
UMLS CUI [2,1]
C0449867
UMLS CUI [2,2]
C1298908
UMLS CUI [2,3]
C0457454
Women of child-bearing potential: women not using an appropriate contraceptive method during the whole duration of study participation (oral contraceptive, intrauterine device, surgical sterilization, parenteral contraception)
Beschreibung

Contraception status

Datentyp

boolean

Alias
UMLS CUI [1]
C0420837
Patient with body weight <50Kg
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
Patients, who in the opinion of the investigator, require a pharmacological prophylaxis in addition to intermittent pneumatic compression
Beschreibung

Prophylactic treatment, Requirement; Pneumatic compression therapy, Requirement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0199176
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C1167944
UMLS CUI [2,2]
C1514873
Treatment Assignment
Beschreibung

Treatment Assignment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C1516050
Date and Time of randomization
Beschreibung

Randomization; Date in time; Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Treatment Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Known pregnancy and/or lactation
Beschreibung

Pregnancy; Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Known pregnancy and/or women who intend to breastfeed
Beschreibung

Pregnancy; Breastfeeding, planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1301732
Patients undergoing vascular surgery
Beschreibung

Vascular Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0042381
Treatment Assignment
Beschreibung

Treatment Assignment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C1516050
Date and Time of randomization
Beschreibung

Randomization; Date in time; Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Treatment Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
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Ähnliche Modelle

Visit 01

1 Formulare
  1. StudyEvent: ODM
    1. Visit 01
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Details of Operation
C0543467 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Item
Type of surgery
text
C0543467 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Operative Surgical Procedures; Type
Code List
Type of surgery
CL Item
Gastrointestinal (Gastrointestinal)
CL Item
Gynecological (Gynecological)
CL Item
Urological (Urological)
CL Item
Other,specify (Other,specify)
Cancer surgery
Item
Cancer surgery
boolean
C0920424 (UMLS CUI [1])
Induction of general anesthesia; Date in time; Time
Item
Date and time of anesthesia induction
datetime
C0473960 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Time of incision
Item
Time of incision
time
C2116297 (UMLS CUI [1])
Time of incision; closure by suture
Item
Time of incision closure
time
C2116297 (UMLS CUI [1,1])
C0009068 (UMLS CUI [1,2])
Item
Type of Anesthesia
text
C1305863 (UMLS CUI [1])
Anesthesia type
Code List
Type of Anesthesia
CL Item
General (General)
CL Item
Spinal/Epidural (Spinal/Epidural)
Peripheral Venous Catheter; Central venous catheter, device
Item
Was any i.v. or central venous line used?
boolean
C2985513 (UMLS CUI [1])
C1145640 (UMLS CUI [2])
Cell saver, Equipment
Item
Was cell saver equipment used?
boolean
C1441512 (UMLS CUI [1,1])
C0014672 (UMLS CUI [1,2])
date time
Item
Date and time of removal of Indewelling Intrathecal or Epidural Catheter
datetime
C3524354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C3524353 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Haematology
C0474523 (UMLS CUI-1)
Item
Post-operative - Prior to first post-operative injection
text
C0474523 (UMLS CUI [1,1])
C2112579 (UMLS CUI [1,2])
Hematology finding, post-operative care
Code List
Post-operative - Prior to first post-operative injection
CL Item
Not done (Not done)
CL Item
Same laboratory as recorded before (Same laboratory as recorded before)
Item
Laboratory Name/City
text
C0474523 (UMLS CUI [1,1])
C1882331 (UMLS CUI [1,2])
Hematology finding, post-operative care
Code List
Laboratory Name/City
CL Item
Not done (Not done)
CL Item
Same laboratory as recorded before (Same laboratory as recorded before)
Hematology finding; Sampling; Date in time; Time
Item
Date and Time of Sampling
datetime
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Test
text
C0474523 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Hematology finding; Hematologic Tests
Code List
Test
CL Item
Platelet (Platelet)
CL Item
Hemoglobin (Hemoglobin)
Hematology finding; Numerical Value
Item
Value
float
C0474523 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
Item
Unit
text
C0474523 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Hematology finding; Unit
Code List
Unit
CL Item
10^9/L (10^9/L)
CL Item
g/dL (g/dL)
Hematology finding; Unit, other
Item
If other unit, specify
text
C0474523 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
major abdominal surgery
Item
Undergoing major abdominal surgery (any surgery between the diaphragm and the pelvic floor) lasting longer than 45 min (duration from induction of anesthesia to closure)
boolean
C0455612 (UMLS CUI [1])
Age
Item
Over 40 years
boolean
C0001779 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Bleeding active, Clinical significance
Item
Active, clinically significant bleeding
boolean
C0741554 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Bleeding tendency, Blood coagulation disorder
Item
Documented congenital or acquired bleeding tendency/disorder(s)
boolean
C1458140 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
Gastrointestinal Diseases
Item
Active ulcerative gastrointestinal disease unless it's the reason for the present surgery
boolean
C0017178 (UMLS CUI [1])
Intracranial Hemorrhages, Recent; Operation on brain, Recent; Spinal Cord, Operative Surgical Procedures, Recent; Ophthalmologic Surgical Procedures, Recent
Item
Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, orophthalmologic surgery
boolean
C0151699 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0195775 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0037925 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0038901 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Catheters, Spinal, Intrathecal
Item
Indwelling intrathecal or epidural catheters for more than 2 hours after surgical closure
boolean
C2584606 (UMLS CUI [1])
Catheter, Spinal, Intrathecal; Function procedure
Item
Patient with indwelling intrathecal or epidural catheter at the time of randomization, or patients who had a traumatic puncture or unusual difficulty in applying the catheter (e.g., more than two attempts or a bloody tap)
boolean
C2584606 (UMLS CUI [1])
C0034117 (UMLS CUI [2])
Cerebral metastasis
Item
Known cerebral metastases
boolean
C0555278 (UMLS CUI [1])
Hemostatic function
Item
Patient in whom hemostasis has not been established 6 hours after surgical closure
boolean
C0019116 (UMLS CUI [1])
Thrombocytopenia
Item
Current thrombocytopenia (<100.000/mm3)
boolean
C0040034 (UMLS CUI [1])
Bacterial Endocarditis
Item
Bacterial endocarditis
boolean
C0014121 (UMLS CUI [1])
Creatinine measurement
Item
Creatinine level above 2.0 mg/dl (180 μmol/L) in a well-hydrated patient
boolean
C0201976 (UMLS CUI [1])
Contrast Media; Hypersensitivity
Item
Documented hypersensitivity to contrast media
boolean
C0009924 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Contrast Media; Medical Contraindication
Item
Use of any contraindicated drug that could not be combined with the injection of contrast medium
boolean
C0009924 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
Peripheral vascular disease; Peripheral ischemia
Item
Patient with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings
boolean
C0085096 (UMLS CUI [1,1])
C0235490 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
major abdominal surgery
Item
Undergoing major abdominal surgery (any surgery between the diaphragm and the pelvic floor) lasting longer than 45 min (duration from induction of anesthesia to closure)
boolean
C0455612 (UMLS CUI [1])
Age
Item
Over 40 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Patient who has signed the informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Bleeding active, Clinical significance
Item
Active, clinically significant bleeding
boolean
C0741554 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Bleeding tendency, Blood coagulation disorder
Item
Documented congenital or acquired bleeding tendency/disorder(s)
boolean
C1458140 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
Gastrointestinal Diseases
Item
Active ulcerative gastrointestinal disease unless it's the reason for the present surgery
boolean
C0017178 (UMLS CUI [1])
Intracranial Hemorrhages, Recent; Operation on brain, Recent; Spinal Cord, Operative Surgical Procedures, Recent; Ophthalmologic Surgical Procedures, Recent
Item
Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, orophthalmologic surgery
boolean
C0151699 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0195775 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0037925 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0038901 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Catheters, Spinal, Intrathecal
Item
Indwelling intrathecal or epidural catheters for more than 2 hours after surgical closure
boolean
C2584606 (UMLS CUI [1])
Catheter, Spinal, Intrathecal; Function procedure
Item
Patient with indwelling intrathecal or epidural catheter at the time of randomization, or patients who had a traumatic puncture or unusual difficulty in applying the catheter (e.g., more than two attempts or a bloody tap)
boolean
C2584606 (UMLS CUI [1])
C0034117 (UMLS CUI [2])
Cerebral metastasis
Item
Known cerebral metastases
boolean
C0555278 (UMLS CUI [1])
Hemostatic function
Item
Patient in whom hemostasis has not been established 6 hours after surgical closure
boolean
C0019116 (UMLS CUI [1])
Thrombocytopenia
Item
Current thrombocytopenia (<100.000/mm3)
boolean
C0040034 (UMLS CUI [1])
Bacterial Endocarditis
Item
Bacterial endocarditis
boolean
C0014121 (UMLS CUI [1])
Creatinine measurement
Item
Creatinine level above 2.0 mg/dl (180 μmol/L) in a well-hydrated patient
boolean
C0201976 (UMLS CUI [1])
Contrast Media; Hypersensitivity
Item
Documented hypersensitivity to contrast media
boolean
C0009924 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Pregnancy; Breast Feeding
Item
Known pregnancy and/or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contrast Media; Medical Contraindication
Item
Use of any contraindicated drug that could not be combined with the injection of contrast medium
boolean
C0009924 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
Peripheral vascular disease; Peripheral ischemia
Item
Patient with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings
boolean
C0085096 (UMLS CUI [1,1])
C0235490 (UMLS CUI [1,2])
Mental Disorders
Item
Mental disorders that could interfere with study participation and/or failure to give written informed consent to take part in the study
boolean
C0004936 (UMLS CUI [1])
Life Expectancy
Item
Patient's life-expectancy < 6 months
boolean
C0023671 (UMLS CUI [1])
Deep Vein Thrombosis
Item
Clinical sign of DVT and/or history of recent DVT (i.e., within the previous 3 months)
boolean
C0149871 (UMLS CUI [1])
Study Subject Participation Status
Item
Participation in any other therapeutic drug study or a device study evaluating DVT prophylaxis within 90 days preceding inclusion
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status; Fondaparinux sodium
Item
Previous participation in a study of fondaparinux sodium
boolean
C2348568 (UMLS CUI [1,1])
C1098510 (UMLS CUI [1,2])
Fondaparinux, Hypersensitivity
Item
Known hypersensitivity to fondaparinux sodium and its excipients
boolean
C1098510 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Mental disorders, Addictive behavior
Item
Current addictive disorders that could interfere with study participation
boolean
C0004936 (UMLS CUI [1,1])
C0085281 (UMLS CUI [1,2])
Use of anticoagulation; preoperative
Item
Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking GPIIb-IIIa platelet receptors two calendar days before surgery
boolean
C0449867 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Anticoagulation contraindicated; Use of anticoagulation, no, Discontinuation (procedure)
Item
Patients for whom anticoagulant therapy was contraindicated or who have, due to concomitant disease, an indication for oral anticoagulant or heparins (including LMWH) and who can not discontinue those treatments
boolean
C1531588 (UMLS CUI [1])
C0449867 (UMLS CUI [2,1])
C1298908 (UMLS CUI [2,2])
C0457454 (UMLS CUI [2,3])
Contraception status
Item
Women of child-bearing potential: women not using an appropriate contraceptive method during the whole duration of study participation (oral contraceptive, intrauterine device, surgical sterilization, parenteral contraception)
boolean
C0420837 (UMLS CUI [1])
Body Weight
Item
Patient with body weight <50Kg
boolean
C0005910 (UMLS CUI [1])
Prophylactic treatment, Requirement; Pneumatic compression therapy, Requirement
Item
Patients, who in the opinion of the investigator, require a pharmacological prophylaxis in addition to intermittent pneumatic compression
boolean
C0199176 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1167944 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Item Group
Treatment Assignment
C0087111 (UMLS CUI-1)
C1516050 (UMLS CUI-2)
Randomization; Date in time; Time
Item
Date and Time of randomization
datetime
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Clinical Trial Subject Unique Identifier
Item
Treatment Number
integer
C2348585 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Pregnancy; Breast Feeding
Item
Known pregnancy and/or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy; Breastfeeding, planned
Item
Known pregnancy and/or women who intend to breastfeed
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Vascular Surgical Procedures
Item
Patients undergoing vascular surgery
boolean
C0042381 (UMLS CUI [1])
Item Group
Treatment Assignment
C0087111 (UMLS CUI-1)
C1516050 (UMLS CUI-2)
Randomization; Date in time; Time
Item
Date and Time of randomization
datetime
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Clinical Trial Subject Unique Identifier
Item
Treatment Number
integer
C2348585 (UMLS CUI [1])
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