Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.

Phase 4

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000007073
• Lead Sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

Brief Summary

Fondaprinux was safe and effective in patients with colorectal cancer resection for the prevention of VTE.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-12-31
• Study Start: 2012-01-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Criteria related to contraindication and warnings and precautions of anticoagulant (Fondaparinux, Heparin, LMWH, danapanoid) 1.Patients with Bleeding 2.Patients with thrombocytopenia (platelet count less than 100,000 /uL) 3.Patients with complications which may cause bleeding (exclude the target disease of surgery) such as gastrointestinal ulceration, gastrointestinal diverticulitis, colitis, acute bacterial endocarditis, uncontrolled severe hypertension, uncontrolled diabetes, DIC. 4.Patients with severe Hepatic impairment (Child-pugh Category C ) 5.Patients with a history of hypersensitivity to heparine, LMWH, danaparoid. 6.Patients with a history of intracerebral hemorrhage. 7.Patients who received brain, spine and eye surgery within 3 months before registration. 8.Patients with severer bleeding than ordinal perioperative bleeding or with difficulty to hemostasis. 9.Severe renal impairment (CCr: less than 20ml / min) -Other exclude criteria 1.Patients who received major orthopedic surgery (lower limbs), abdominal surgery and cardiovascular surgery within 3 months before the study registration. 2.Patients who received prohibited concomitant drug as follows; Heparin, LMWH, danaparoid, antithrombotic drug, oral anticoagulant (warfalin) , thrombolytic drug, dextran, anti platelet drug (aspirin, clopidogrel, ticlopidine) 3.Patients who diagnosed as VTE at preoperative test 4.Patients whose preoperative D-dimer values are more than 1ug/ml, or 2 times of standard value in the hospital 5.Patients with a history of arterial thromboembolism. 6.Patients with drug addiction or alcoholism 7.Patients who are scheduled other surgery in the study period 8.pregnancy or possibility of pregnant 9.Patients who were tried insertion more than 2 times when catheterization Patients who are regarded ineligible by doctors with any other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major bleeding event rate

Secondary Outcome Measures

Name	Time	Method
Frequency of symptomatic PTE or symptomatic DVT