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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007073

Enrollment

600

Registered

2012-01-16

Start date

2009-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Start injection of Fondaparinux from 24 +/- 2 hours after surgery and continue administration for 4-8 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who had Colon cancer surgery and have additional risk factor in Japanese Guideline for Prevention of Venous Thromboembolism 2. Patients who can give informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Major bleeding event rate	—

Secondary

Measure	Time frame
Frequency of symptomatic PTE or symptomatic DVT	—

Countries

Japan

Contacts

Public ContactMasataka Ikeda

Graduate School of Medicine, Osaka University Department of Surgery, Gastroenterological Surgery

mikeda@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026