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Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Mandatory Venography Adjudication

- 16/09/2019 - 1 Formulaire, 5 Groupes Item, 15 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Mandatory Venography Adjudication, Venography Adjudication Results, Overall assessment, Adjudicators
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 information on the adjudication of the mandatory venography which is performed between Day 5 and 10 (not more than one day after the last study drug dose), i.e. Visit 2, to check for asymptomatic deep vein thrombosis, and is recorded in a seperate form.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Unusual Bleeding Form

- 16/09/2019 - 1 Formulaire, 3 Groupes Item, 12 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Unusual Bleeding, Bleeding AE form Numbers
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 information on unusual bleeding events and is to be filled in as appropriate during the study.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Death Adjudication

- 16/09/2019 - 1 Formulaire, 4 Groupes Item, 11 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Death Event Adjudication, Classification, Adjudicators
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 information on the adjudication of any death occuring during the study.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Suspected DVT Adjudication

- 16/09/2019 - 1 Formulaire, 6 Groupes Item, 19 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Suspected DVT Adjudication, Suspected DVT Adjudication Results, Venography Adjudication Results, Classification, Adjudicators
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 information on the adjudication of any suspected DVT, information on which is recorded in a seperate form.

Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Study ID: 104574 - Blinded Anticoagulation Form

- 28/08/2018 - 1 Formulaire, 3 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Administrative Data, Study Drug Accountability, ACT Measurement
Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism

Contact and Follow Up Bridging UK Essen

- 28/11/2016 - 1 Formulaire, 2 Groupes Item, 29 Eléments de données, 1 Langue
Groupes Item: Contact attempt, Follow Up
A prospective register study, investigating the change from Marcumar to Heparin in surgical patients. This is the fourth of its kind (Bridging). Authorisation granted by Mrs. Ose (Frau Ose), ZKS Essen (UK Essen)

Protocol violation RICH study NCT02669589

- 08/07/2016 - 1 Formulaire, 3 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Patient Information, Protocol violation, Identification and Signature
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Adverse Event: Citrate RICH study NCT02669589 - Adverse Event: Citrat RICH study NCT02669589

- 08/07/2016 - 1 Formulaire, 6 Groupes Item, 21 Eléments de données, 1 Langue
Groupes Item: Patient Information, Adverse Event Description, Duration, Therapy, Comments, Case report form data
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Adverse Event: Heparin RICH study NCT02669589

- 08/07/2016 - 1 Formulaire, 6 Groupes Item, 21 Eléments de données, 1 Langue
Groupes Item: Patient Information, Adverse Event Description, Duration, Therapy, Comments, Case report form data
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Pre-Screening Log RICH study NCT02669589

- 08/07/2016 - 1 Formulaire, 3 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Patient Information, Inclusion Criteria, Reason for Exclusion
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Consent RICH study NCT02669589

- 04/07/2016 - 1 Formulaire, 3 Groupes Item, 16 Eléments de données, 1 Langue
Groupes Item: Patient Information, Subsequent consent, Withdrawal of consent
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

ICU - Hospital Stay RICH study NCT02669589

- 04/07/2016 - 1 Formulaire, 3 Groupes Item, 14 Eléments de données, 1 Langue
Groupes Item: Patient Information, Discharge Date, Further Hospital Stays
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

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