Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038961
Status:
COMPLETED
Last Update Posted:
2016-09-01
First Post:
2002-06-05
Brief Title:
A Study to Evaluate the Efficacy and Safety of Fondaparinux Sodium When Used With Intermittent Pneumatic Compression to Prevent Venous Thromboembolic IPC Versus IPC Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal Surgery APOLLO
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official 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 Abdomi
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicentre randomized double-blind placebo controlled study During this study all the patients will receive background venous thromboembolism VTE mechanical prophylaxis with intermittent pneumatic compression IPC
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled study evaluating the safety and efficacy of fondaparinux in the prevention of venous thromboembolism VTE in subjects undergoing abdominal surgery at increased risk for VTE During this study all subjects were to receive background VTE prophylaxis with intermittent pnuematic compression IPC elastic stockings ES
Screening Period Day -30-Day 0 all subjects at increased risk of VTE undergoing abdominal surgery and fulfilled the study entry criteria were eligible for the study
Treatment Period Day 7 2 At the baseline assessment on the day of surgery Day 1 subjects who satisfied all inclusionexclusion criteria were randomized 11 to receive either fondaparinux or placebo All the subjects were to receive background therapy with IPC ES The first administration of either fondaparinux 25mg or placebo was to take place 6 to 8 hours after surgical closure provided hemostasis was achieved Thereafter a once daily subcutaneous injection of either fondaparinux 25mg or placebo was to be administered up to Day 7 2 During the treatment phase subjects were assessed daily A mandatory venogram was performed between Day 5 and 10 or earlier in the case of symptomatic VTE but not more than 1 calendar day after the last study treatment administration
Follow up Period Day 30 2 A follow-up visit or contact was to take place at Day 30 2 days Use of antithrombotic therapy for prevention of VTE after the mandatory venographyand during the entire Follow-up Period was left to the investigators discretion
Screening Period Day -30-Day 0 all subjects at increased risk of VTE undergoing abdominal surgery and fulfilled the study entry criteria were eligible for the study
Treatment Period Day 7 2 At the baseline assessment on the day of surgery Day 1 subjects who satisfied all inclusionexclusion criteria were randomized 11 to receive either fondaparinux or placebo All the subjects were to receive background therapy with IPC ES The first administration of either fondaparinux 25mg or placebo was to take place 6 to 8 hours after surgical closure provided hemostasis was achieved Thereafter a once daily subcutaneous injection of either fondaparinux 25mg or placebo was to be administered up to Day 7 2 During the treatment phase subjects were assessed daily A mandatory venogram was performed between Day 5 and 10 or earlier in the case of symptomatic VTE but not more than 1 calendar day after the last study treatment administration
Follow up Period Day 30 2 A follow-up visit or contact was to take place at Day 30 2 days Use of antithrombotic therapy for prevention of VTE after the mandatory venographyand during the entire Follow-up Period was left to the investigators discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None