CTRI/2019/07/020134RecruitingPhase 3
A randomized controlled trial of oral Apixaban compared to parenteral Enoxaparin for prevention of venous thromboembolism in patients undergoing gynecologic cancer surgery
Christian Medical College Vellore0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1) Objective diagnosis of gynaecological malignancy
- •2) Planned major surgery for gynaecological malignancies
- •3) Antithrombotic prophylaxis with LMWH administered for 7 ± 2 days after surgery
Exclusion Criteria
- •1) Age <18 years
- •2) Surgery for non-cancer disease
- •3) Duration of surgery < 45 min
- •4) Pre-existing DVT/PE
- •5) Other indication for anticoagulant therapy
- •6) Known cerebral metastases
- •7) Kidney or liver failure (creatinine clearance <30 mL /min based on the Cockcroft Gault equation; acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more than the upper limit of the normal range);
- •8) Known haemorrhagic diathesis or high risk for bleeding
- •9) History of intracerebral bleeding or neurosurgery within 6 months
- •10) History of heparin induced thrombocytopenia
- •11) Pregnancy or lactation
- •12) Refusal of informed consent
Investigators
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