ID

38389

Beschreibung

Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains the study's Eligbility Criteria, which are checked at Visit 1 (on Day 1, the day of the surgery).

Link

https://clinicaltrials.gov/ct2/show/NCT00038961

Stichworte

Versionen (1)
  1. 15/10/2019 15/10/2019 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15 de outubro de 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961

Englisch

Eligibility Criteria

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

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Beschreibung

Country No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0454664
UMLS CUI [1,2]
C0600091
Centre No.
Beschreibung

Centre No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject No.
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
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

Long major abdominal surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0198482
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C4540902
Over 40 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion criteria based on current risk of bleeding
Beschreibung

Exclusion criteria based on current risk of bleeding

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C3251812
Active, clinically significant bleeding
Beschreibung

Active, clinically significant bleeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2707252
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0019080
Documented congenital or acquired bleeding tendency/disorder(s)
Beschreibung

Documented congenital or acquired bleeding tendency/disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301725
UMLS CUI [1,2]
C1458140
UMLS CUI [1,3]
C1744681
UMLS CUI [2,1]
C1301725
UMLS CUI [2,2]
C0005779
UMLS CUI [2,3]
C1744681
UMLS CUI [3,1]
C1301725
UMLS CUI [3,2]
C1458140
UMLS CUI [3,3]
C0439661
UMLS CUI [4,1]
C1301725
UMLS CUI [4,2]
C0005779
UMLS CUI [4,3]
C0439661
Active ulcerative gastrointestinal disease unless it's the reason for the present surgery
Beschreibung

Active ulcerative gastrointestinal disease unless reason for surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237938
UMLS CUI [1,2]
C2707252
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0237938
UMLS CUI [2,3]
C2707252
UMLS CUI [2,4]
C0566251
UMLS CUI [2,5]
C0543467
Recent intracranial hemorrhage or recent brain, spinal, or ophthalmologic surgery
Beschreibung

for surgery: less than 3 months prior to randomisation

Datentyp

boolean

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

Indwelling intrathecal/epidural catheter remaining after surgery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0179751
UMLS CUI [1,2]
C0007439
UMLS CUI [1,3]
C1527428
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0543467
UMLS CUI [2,1]
C2584606
UMLS CUI [2,2]
C0007439
UMLS CUI [2,3]
C1527428
UMLS CUI [2,4]
C0687676
UMLS CUI [2,5]
C0543467
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

Indwelling intrathecal/epidural catheter at randomization, traumatic puncture or difficult implantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0179751
UMLS CUI [1,2]
C0007439
UMLS CUI [1,3]
C0034656
UMLS CUI [2,1]
C2584606
UMLS CUI [2,2]
C0007439
UMLS CUI [2,3]
C0034656
UMLS CUI [3,1]
C2721760
UMLS CUI [3,2]
C0007439
UMLS CUI [3,3]
C2095370
UMLS CUI [4,1]
C2721760
UMLS CUI [4,2]
C0007439
UMLS CUI [4,3]
C2095369
UMLS CUI [5,1]
C0332218
UMLS CUI [5,2]
C0007439
UMLS CUI [5,3]
C2095370
UMLS CUI [6,1]
C0332218
UMLS CUI [6,2]
C0007439
UMLS CUI [6,3]
C2095369
Known cerebral metastases
Beschreibung

Known cerebral metastases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205309
Patient in whom hemostasis has not been established 6 hours after surgical closure
Beschreibung

Surgical hemostasis late

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019117
UMLS CUI [1,2]
C0205087
Current thrombocytopenia
Beschreibung

<100.000/mm³

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0521116
Bacterial endocarditis
Beschreibung

Bacterial endocarditis

Datentyp

boolean

Alias
UMLS CUI [1]
C0014121
Exclusion criteria related to study procedures (venography, intermittent pneumatic compression or elastic stockings)
Beschreibung

Exclusion criteria related to study procedures (venography, intermittent pneumatic compression or elastic stockings)

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0680734
Creatinine level above 2.0 mg/dl (180 μmol/L) in a well-hydrated patient
Beschreibung

Creatinine level in well-hydrated state

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C4264325
Documented hypersensitivity to contrast media
Beschreibung

Documented hypersensitivity to contrast media

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0570562
UMLS CUI [1,2]
C1301725
Use of any contraindicated drug that could not be combined with the injection of contrast medium
Beschreibung

Other drug contraindicating contrast media injection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C0009924
Patient with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings
Beschreibung

Leg ischemia caused by peripheral vascular disease, IPC or elastic stockings contraindicated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1579665
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0085096
UMLS CUI [2,1]
C1998430
UMLS CUI [2,2]
C0522473
UMLS CUI [3,1]
C0522473
UMLS CUI [3,2]
C2064695
Exclusion criteria related to trial methodology
Beschreibung

Exclusion criteria related to trial methodology

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C2348563
Mental disorders that could interfere with study participation and/or failure to give written informed consent to take part in the study
Beschreibung

Mental disorder interfering with study participation and/or no informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0332197
Patient's life-expectancy < 6 months
Beschreibung

Limited life expectancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
Clinical sign of DVT and/or history of recent DVT (i.e., within the previous 3 months)
Beschreibung

Signs of DVT and/or recent DVT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0037088
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0149871
Participation in any other therapeutic drug study or a device study evaluating DVT prophylaxis within 90 days preceding inclusion
Beschreibung

Recent participation in other drug study or device study for DVT prophylaxis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C2346570
UMLS CUI [2,5]
C0853245
Previous participation in a study of fondaparinux sodium
Beschreibung

Previous participation in a study of fondaparinux sodium

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1098510
Known hypersensitivity to fondaparinux sodium and its excipients
Beschreibung

Known hypersensitivity to fondaparinux sodium and its excipients

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1098510
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1098510
UMLS CUI [2,3]
C0015237
Current addictive disorders that could interfere with study participation
Beschreibung

Current addictive disorders that could interfere with study participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C4324263
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking GPIIb-IIIa platelet receptors two calendar days before surgery
Beschreibung

Recent preoperative administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking GPIIb-IIIa platelet receptors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C0019134
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0445204
UMLS CUI [2,3]
C0019142
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0445204
UMLS CUI [3,3]
C0019139
UMLS CUI [4,1]
C0332185
UMLS CUI [4,2]
C0445204
UMLS CUI [4,3]
C0354604
UMLS CUI [5,1]
C0332185
UMLS CUI [5,2]
C0445204
UMLS CUI [5,3]
C0011806
UMLS CUI [6,1]
C0332185
UMLS CUI [6,2]
C0445204
UMLS CUI [6,3]
C0019573
UMLS CUI [7,1]
C0332185
UMLS CUI [7,2]
C0445204
UMLS CUI [7,3]
C0016018
UMLS CUI [8,1]
C0332185
UMLS CUI [8,2]
C0445204
UMLS CUI [8,3]
C0864559
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 cannot discontinue those treatments
Beschreibung

Anticoagulant therapy contraindicated or indication for oral anticoagulants/heparins/LMWH due to concomitant disease which cannot be discontinued

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0522473
UMLS CUI [2,1]
C0243087
UMLS CUI [2,2]
C0392360
UMLS CUI [2,3]
C0354604
UMLS CUI [3,1]
C0243087
UMLS CUI [3,2]
C0392360
UMLS CUI [3,3]
C0019134
UMLS CUI [4,1]
C0243087
UMLS CUI [4,2]
C0392360
UMLS CUI [4,3]
C0019139
UMLS CUI [5,1]
C0003281
UMLS CUI [5,2]
C1299582
UMLS CUI [5,3]
C0457454
Women of child-bearing potential: women not using an appropriate contraceptive method during the whole duration of study participation
Beschreibung

oral contraceptive, intrauterine device, surgical sterilization, parenteral contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C2347804
Miscellaneous exclusion criteria
Beschreibung

Miscellaneous exclusion criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0205395
Known pregnancy and/or lactation
Beschreibung

Known pregnancy and/or lactation

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

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)
Country No.
Item
Country No.
integer
C0454664 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Centre No.
Item
Centre No.
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Long 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
C0198482 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C4540902 (UMLS CUI [2])
Age
Item
Over 40 years
boolean
C0001779 (UMLS CUI [1])
Item Group
Exclusion criteria based on current risk of bleeding
C0680251 (UMLS CUI-1)
C3251812 (UMLS CUI-2)
Active, clinically significant bleeding
Item
Active, clinically significant bleeding
boolean
C2707252 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
Documented congenital or acquired bleeding tendency/disorder
Item
Documented congenital or acquired bleeding tendency/disorder(s)
boolean
C1301725 (UMLS CUI [1,1])
C1458140 (UMLS CUI [1,2])
C1744681 (UMLS CUI [1,3])
C1301725 (UMLS CUI [2,1])
C0005779 (UMLS CUI [2,2])
C1744681 (UMLS CUI [2,3])
C1301725 (UMLS CUI [3,1])
C1458140 (UMLS CUI [3,2])
C0439661 (UMLS CUI [3,3])
C1301725 (UMLS CUI [4,1])
C0005779 (UMLS CUI [4,2])
C0439661 (UMLS CUI [4,3])
Active ulcerative gastrointestinal disease unless reason for surgery
Item
Active ulcerative gastrointestinal disease unless it's the reason for the present surgery
boolean
C0237938 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0237938 (UMLS CUI [2,2])
C2707252 (UMLS CUI [2,3])
C0566251 (UMLS CUI [2,4])
C0543467 (UMLS CUI [2,5])
Recent intracranial hemorrhage or brain, spinal, or ophthalmologic surgery
Item
Recent intracranial hemorrhage or recent brain, spinal, or ophthalmologic surgery
boolean
C0332185 (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])
Indwelling intrathecal/epidural catheter remaining after surgery
Item
Indwelling intrathecal or epidural catheters for more than 2 hours after surgical closure
boolean
C0179751 (UMLS CUI [1,1])
C0007439 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,5])
C2584606 (UMLS CUI [2,1])
C0007439 (UMLS CUI [2,2])
C1527428 (UMLS CUI [2,3])
C0687676 (UMLS CUI [2,4])
C0543467 (UMLS CUI [2,5])
Indwelling intrathecal/epidural catheter at randomization, traumatic puncture or difficult implantation
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
C0179751 (UMLS CUI [1,1])
C0007439 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
C2584606 (UMLS CUI [2,1])
C0007439 (UMLS CUI [2,2])
C0034656 (UMLS CUI [2,3])
C2721760 (UMLS CUI [3,1])
C0007439 (UMLS CUI [3,2])
C2095370 (UMLS CUI [3,3])
C2721760 (UMLS CUI [4,1])
C0007439 (UMLS CUI [4,2])
C2095369 (UMLS CUI [4,3])
C0332218 (UMLS CUI [5,1])
C0007439 (UMLS CUI [5,2])
C2095370 (UMLS CUI [5,3])
C0332218 (UMLS CUI [6,1])
C0007439 (UMLS CUI [6,2])
C2095369 (UMLS CUI [6,3])
Known cerebral metastases
Item
Known cerebral metastases
boolean
C0220650 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
Surgical hemostasis late
Item
Patient in whom hemostasis has not been established 6 hours after surgical closure
boolean
C0019117 (UMLS CUI [1,1])
C0205087 (UMLS CUI [1,2])
Current Thrombocytopenia
Item
Current thrombocytopenia
boolean
C0040034 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Bacterial endocarditis
Item
Bacterial endocarditis
boolean
C0014121 (UMLS CUI [1])
Item Group
Exclusion criteria related to study procedures (venography, intermittent pneumatic compression or elastic stockings)
C0680251 (UMLS CUI-1)
C0680734 (UMLS CUI-2)
Creatinine level in well-hydrated state
Item
Creatinine level above 2.0 mg/dl (180 μmol/L) in a well-hydrated patient
boolean
C0201976 (UMLS CUI [1,1])
C4264325 (UMLS CUI [1,2])
Documented hypersensitivity to contrast media
Item
Documented hypersensitivity to contrast media
boolean
C0570562 (UMLS CUI [1,1])
C1301725 (UMLS CUI [1,2])
Other drug contraindicating contrast media injection
Item
Use of any contraindicated drug that could not be combined with the injection of contrast medium
boolean
C2347852 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0009924 (UMLS CUI [1,3])
Leg ischemia caused by peripheral vascular disease, IPC or elastic stockings contraindicated
Item
Patient with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings
boolean
C1579665 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0085096 (UMLS CUI [1,3])
C1998430 (UMLS CUI [2,1])
C0522473 (UMLS CUI [2,2])
C0522473 (UMLS CUI [3,1])
C2064695 (UMLS CUI [3,2])
Item Group
Exclusion criteria related to trial methodology
C0680251 (UMLS CUI-1)
C2348563 (UMLS CUI-2)
Mental disorder interfering with study participation and/or no informed consent
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 [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Limited life expectancy
Item
Patient's life-expectancy < 6 months
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Signs of DVT and/or recent DVT
Item
Clinical sign of DVT and/or history of recent DVT (i.e., within the previous 3 months)
boolean
C0149871 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0149871 (UMLS CUI [2,2])
Recent participation in other drug study or device study for DVT prophylaxis
Item
Participation in any other therapeutic drug study or a device study evaluating DVT prophylaxis within 90 days preceding inclusion
boolean
C0332185 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0332185 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C2346570 (UMLS CUI [2,4])
C0853245 (UMLS CUI [2,5])
Previous participation in a study of fondaparinux sodium
Item
Previous participation in a study of fondaparinux sodium
boolean
C0205156 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1098510 (UMLS CUI [1,3])
Known hypersensitivity to fondaparinux sodium and its excipients
Item
Known hypersensitivity to fondaparinux sodium and its excipients
boolean
C0020517 (UMLS CUI [1,1])
C1098510 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1098510 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Current addictive disorders that could interfere with study participation
Item
Current addictive disorders that could interfere with study participation
boolean
C0521116 (UMLS CUI [1,1])
C4324263 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Recent preoperative administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking GPIIb-IIIa platelet receptors
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
C0332185 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0019134 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C0019142 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
C0019139 (UMLS CUI [3,3])
C0332185 (UMLS CUI [4,1])
C0445204 (UMLS CUI [4,2])
C0354604 (UMLS CUI [4,3])
C0332185 (UMLS CUI [5,1])
C0445204 (UMLS CUI [5,2])
C0011806 (UMLS CUI [5,3])
C0332185 (UMLS CUI [6,1])
C0445204 (UMLS CUI [6,2])
C0019573 (UMLS CUI [6,3])
C0332185 (UMLS CUI [7,1])
C0445204 (UMLS CUI [7,2])
C0016018 (UMLS CUI [7,3])
C0332185 (UMLS CUI [8,1])
C0445204 (UMLS CUI [8,2])
C0864559 (UMLS CUI [8,3])
Anticoagulant therapy contraindicated or indication for oral anticoagulants/heparins/LMWH due to concomitant disease which cannot be discontinued
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 cannot discontinue those treatments
boolean
C0003281 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0243087 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
C0354604 (UMLS CUI [2,3])
C0243087 (UMLS CUI [3,1])
C0392360 (UMLS CUI [3,2])
C0019134 (UMLS CUI [3,3])
C0243087 (UMLS CUI [4,1])
C0392360 (UMLS CUI [4,2])
C0019139 (UMLS CUI [4,3])
C0003281 (UMLS CUI [5,1])
C1299582 (UMLS CUI [5,2])
C0457454 (UMLS CUI [5,3])
Women of child-bearing potential not using an appropriate contraception during study period
Item
Women of child-bearing potential: women not using an appropriate contraceptive method during the whole duration of study participation
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
Item Group
Miscellaneous exclusion criteria
C0680251 (UMLS CUI-1)
C0205395 (UMLS CUI-2)
Known pregnancy and/or lactation
Item
Known pregnancy and/or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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