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).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- venous thromboembolism (VTE) [ Time Frame: adjudicated mandatory venogram positive for DVT between day 5 and day 10; up to day 10 for symptomatic DVT and/or adjudicated non fatal Pe , adjudicated fatal PE ]the incidence of VTE determined as any of the following VTE outcomes recorded up to the first venogram performed or up to Day 10, whichever occurred first: adjudicated manadatory veongram positive for DVT between Day 5 and Day 10; adjudicated symptomatic DVT and/or adjudicated non-fatal PE; adjudicated fatal PE
- major bleeding [ Time Frame: first study drug injection to 2 days after last study drug injection and first study drug injection up to Day 32 ]adjudicated major bleeding
- deep vein thrombosis (DVT) [ Time Frame: up to Day 10 ]Incidence of any DVT, any proximal DVT, and distal only DVT
- symptomatic VTE (venous thromboembolism) [ Time Frame: up to Day 10 and up to Day 32 ]Incidence of adjudicated symptomatic VTE (DVT, non fatal pulmonary embolism (PE), and fatal PE)
- initiation of curative treatment [ Time Frame: 3 years ]Initiation of curative treatment after VTE assessment used for the primary endpoint evaluation
- any VTE and all deaths [ Time Frame: up to Day 10 ]incidence of any VTE and all deaths
- symptomatic VTE and all deaths [ Time Frame: up to Day 32 ]incidence of adjudicated symptomatic VTE and all deaths
- minor bleeding [ Time Frame: treatment period and up to day 32 ]adjudicated minor bleeding
- All major or minor bleeding [ Time Frame: 3 years ]All adjudicated (major or minor) bleeding
- Adverse events [ Time Frame: 3 years ]Adverse Events (AEs/serious adverse events (SAEs))
- Transfusion [ Time Frame: 3 years ]the need for transfusion and total blood units transfused
- Lab parameters [ Time Frame: 3 years ]changes from baseline in laboratory parameters
- Death [ Time Frame: 3 years ]Death
|Study Start Date:||November 2001|
|Study Completion Date:||October 2004|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo + intermittent pneumatic compression (IPC)||
placebo, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)
|Experimental: fondaparinux + intermittent pneumatic compression (IPC)||
Drug: fondaparinux sodium
2.5 mg fondparinux sodium, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)
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 inclusion/exclusion criteria were randomized (1:1) to receive either fondaparinux or placebo. All the subjects were to receive background therapy with IPC ±ES. The first administration of either fondaparinux 2.5mg 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 2.5mg 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 investigator's discretion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038961
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|