Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium)

Launched by ITALFARMACO · Aug 3, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • both sexes;aged\>18 years;
• • suffering from different types of malignancies(lung, breast,gastric,colon- rectum,pancreatic,ovarian,head and neck cancer)undergoing systemic chemotherapy,
• • having signed Informed Consent prior to initiation of any study procedure.
• EXCLUSION CRITERIA:
• • adjuvant and neo-adjuvant chemotherapy;
• • objectively confirmed venous or arterial thromboembolism in the last three months;
• • antithrombotic treatment for other indications;
• • life expectancy of less than 3 months;
• • Performance Status\>2(ECOG);
• • active bleeding or bleedings in the last four weeks requiring hospitalization,transfusion or surgical intervention;
• • bleeding diathesis(prothrombin time\<70% or activated partial thromboplastin time ratio\>1.3),or platelet count\<50x10\^9/L;
• • cerebrovascular hemorrhage in the last six months;
• • known active gastric or duodenal ulcer;
• • known cerebral metastasis;
• • cerebral aneurysm;
• • III-IV grade diabetic retinopathy;
• • severe and uncontrolled hypertension(systolic blood pressure\>180 mmHg or diastolic blood pressure\>110 mmHg);
• • chronic atrial fibrillation;
• • acute endocarditis;
• • acute pancreatitis;
• • known hypersensitivity to unfractionated heparin or LMWH;
• • previous occurrence of heparin-induced thrombocytopenia;
• • renal impairment (dependent on dialysis or creatinine higher than 2.5mg%);
• • liver insufficiency (alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase levels\>3 times the upper limit of the normal ranges and/or total bilirubin \>3.0 mg/ml);
• • pregnancy or childbearing potential without adequate contraception;
• • treatment with other investigational drugs or patient inclusion in other clinical trials;
• • patients who are unable to fulfill the study requirements in terms of visits/compliance to treatment.