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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,309
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)
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)
venous thromboembolism (VTE)
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
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
major bleeding
adjudicated 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
deep vein thrombosis (DVT)
Incidence of any DVT, any proximal DVT, and distal only DVT
Time frame: up to Day 10
symptomatic VTE (venous thromboembolism)
Incidence of adjudicated symptomatic VTE (DVT, non fatal pulmonary embolism (PE), and fatal PE)
Time frame: up to Day 10 and up to Day 32
initiation of curative treatment
Initiation of curative treatment after VTE assessment used for the primary endpoint evaluation
Time frame: 3 years
any VTE and all deaths
incidence of any VTE and all deaths
Time frame: up to Day 10
symptomatic VTE and all deaths
incidence of adjudicated symptomatic VTE and all deaths
Time frame: up to Day 32
minor bleeding
adjudicated minor bleeding
Time frame: treatment period and up to day 32
All major or minor bleeding
All adjudicated (major or minor) bleeding
Time frame: 3 years
Adverse events
Adverse Events (AEs/serious adverse events (SAEs))
Time frame: 3 years
Transfusion
the need for transfusion and total blood units transfused
Time frame: 3 years
Lab parameters
changes from baseline in laboratory parameters
Time frame: 3 years
Death
Death
Time frame: 3 years
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