Apixaban tablet versus Enoxaparin for prevention of venous thromboembolism in women undergoing surgery for gynecological cancers
- Conditions
- Health Condition 1: Z790- Long term (current) use of anticoagulants and antithrombotics/antiplatelets
- Registration Number
- CTRI/2019/07/020134
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method