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).

NCT00038961 | Completed Phase 3 DMC

• 1 other identifier: 103414
• Study Type: interventional
• Target: 1,309
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Thromboembolism

Keywords

fondaparinux sodium; DVT Prevention; abdominal surgery; VTE prevention; venous thromboembolism; pulmonary embolism

Outcome Measures

Primary Outcomes (2)

• 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

  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

  first study drug injection to 2 days after last study drug injection and first study drug injection up to Day 32

Secondary Outcomes (11)

• deep vein thrombosis (DVT)

  up to Day 10

• symptomatic VTE (venous thromboembolism)

  up to Day 10 and up to Day 32

• initiation of curative treatment

  3 years

• any VTE and all deaths

  up to Day 10

• symptomatic VTE and all deaths

  up to Day 32

Study Arms (2)

Placebo + intermittent pneumatic compression (IPC)

PLACEBO COMPARATOR

Other: placebo

fondaparinux + intermittent pneumatic compression (IPC)

EXPERIMENTAL

Drug: fondaparinux sodium

Interventions

fondaparinux sodium DRUG

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)

fondaparinux + intermittent pneumatic compression (IPC)

placebo OTHER

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)

Placebo + intermittent pneumatic compression (IPC)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor) lasting longer than 45 minutes (duration from anesthesia induction to surgical closure)
• Over 40 years of age
• Subject who had signed the informed consent.

You may not qualify if:

• Active, clinically significant bleeding
• Documented congenital or acquired bleeding tendency/disorders
• Active ulcerative gastrointestinal disease unless the reason for the present surgery.
• Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, or ophthalmologic surgery.
• Indwelling intrathecal or epidural catheters for more than 6 hours after surgical closure.
• Subjects who had a traumatic puncture or unusual difficulty in applying the catheter
• Known cerebral metastasis,
• Subjects in whom hemostasis had not been established 6 hours after surgical closure,
• Current thrombocytopenia,
• Bacterial endocarditis
• Creatinine level above 2.0 mg/dL (180 μmol/L) in a well-hydrated subject,
• Documented hypersensitivity to contrast media,
• Use of any contraindicated drug that could not be combined with the injection of contrast medium,
• Patent with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings.
• Mental disorders that could interfere with study participation and/or failure to give written informed consent to take part in the study,

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Sanofi: collaborator

Related Publications (1)

• Turpie AG, Bauer KA, Caprini JA, Comp PC, Gent M, Muntz JE; Apollo Investigators. Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery: a randomized, double-blind comparison. J Thromb Haemost. 2007 Sep;5(9):1854-61. doi: 10.1111/j.1538-7836.2007.02657.x.

  PMID: 17723125 RESULT

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Thromboembolism; Venous Thromboembolism; Pulmonary Embolism

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2002
• First Posted: June 10, 2002
• Study Start: November 1, 2001
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: September 1, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share