Last updated: 11/07/2018 00:07:30

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).

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GSK study ID
103414
See study documents
Clinicaltrials.gov ID
NCT00038961
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial 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
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

venous thromboembolism (VTE)

Timeframe: 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

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

Secondary outcomes:

deep vein thrombosis (DVT)

Timeframe: up to Day 10

symptomatic VTE (venous thromboembolism)

Timeframe: up to Day 10 and up to Day 32

initiation of curative treatment

Timeframe: 3 years

any VTE and all deaths

Timeframe: up to Day 10

symptomatic VTE and all deaths

Timeframe: up to Day 32

minor bleeding

Timeframe: treatment period and up to day 32

All major or minor bleeding

Timeframe: 3 years

Adverse events

Timeframe: 3 years

Transfusion

Timeframe: 3 years

Lab parameters

Timeframe: 3 years

Death

Timeframe: 3 years

Interventions:
  • Drug: fondaparinux sodium
  • Other: placebo
    • Enrollment:
    1309
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Turpie AGG, Bauer KA, Caprini JA, Comp PC, Gent M and Muntz JE. Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery: a randomized, double-blind comparison. Journal of Thrombosis and Haemostasis, 4: 1854-1861, 1007
    Medical condition
    Thromboembolism
    Product
    fondaparinux sodium
    Collaborators
    Sanofi Aventis
    Study date(s)
    November 2001 to October 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • 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
    • Active, clinically significant bleeding
    • Documented congenital or acquired bleeding tendency/disorders
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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.
    Exclusion criteria:
    • 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. Exclusion criteria related to trial methodology:
    • Mental disorders that could interfere with study participation and/or failure to give written informed consent to take part in the study,
    • Subject’s life expectancy < 6 months,
    • Clinical sign of DVT and/or history of recent DVT,
    • Participation in any other therapeutic drug study or a device study evaluating DVT prophylaxis within 90 days preceding inclusion,
    • Previous participation in a study of fondaparinux sodium,
    • Known hypersensitivity to fondaparinux and its excipients,
    • Current addictive disorders that could interfere with study participation,
    • Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking glycoprotein platelet receptors (GPIIb-IIIa) during the screening period, i.e., from admission to surgery,
    • Subjects for whom anticoagulant therapy was contraindicated or who had, due to concomitant disease, an indication for oral anticoagulant or heparins (including LMWH) and who could not discontinue those treatments,
    • Women of child-bearing potential: women not using an appropriate contraceptive method during the whole duration of study participation ,
    • Subject with body weight <50 kg,
    • Subjects, who in the opinion of the investigator, required a pharmacological prophylaxis in addition to intermittent pneumatic compression,
    • Known pregnancy and / or women who intended to breastfeed,
    • Subjects undergoing vascular surgery such as aorto-femoral bypass graft

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-27-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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