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).
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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.
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