JPRN-UMIN000008435CompletedPhase 3
Phase III study of efficacy of fondaparinux on the prevention of post-operative venous thromboembolism in patients undergoing with laparoscopic colorectal cancer surgery. - Phase III VTE prevention study of fondaparinux in colorectal cancer patients.
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group0 sites300 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 40years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1) Patients with active bleeding 2)Thrombocytopenia plt<10x104/uL 3) Patients with a risk of bleeding: GI ulcers, diverticulitis, colitis, acute bacterial endocarditis, uncontrolled severe hypertension, Uncontrolled diabetes mellitus, DIC 4) Severe liver dysfunction (Child C) 5) Known hypersensitivity of unfractionated heparin, low molecular heparin, and heparinoids) 6) History of cranial bleeding 7) Patients underwent central cranial operation, spine operation or ophthalmic surgery within 3 months before registration 8) Severe renal dysfunction (Cr clearance < 20ml/min) 9) Known hypersensitivity of contrast media 10) Other patients who are unfit for the study as determined by the attending physician.
Investigators
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