The impact of Thromboprophylaxis on Progression Free Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) study - imPaCT-PRO

Institute of Molecular Medicine and Biomedical Research (IMBE)0 个研究点目标入组 450 人开始时间: 2021年11月12日最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•1.Locally Advanced or metastatic PC (confirmed by the recommended histological and imaging methods).
•2.Age = 18 years.
•3.Planning to start 1st line chemotherapy with NabG.
•4.Eastern Cooperative Group (ECOG) 0-2.
•5.Life expectancy >6 months.
•6.Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•1.Subjects with contraindication to receive anticoagulant:
•a. Any hypersensitivity to anticoagulant or excipients.
•b. History of heparin-induced thrombocytopenia type II (HIT II).
•c. Active major bleeding or pre-diathesis for major bleeding
•d. Septic endocarditis.
•2.Creatinine clearance <20 mL/min according to Cockcroft-Gault formula.
•3.Platelet count < 50 G/L at inclusion.
•4.Hepatic dysfunction defined as at least one of the following: AST and/or ALT > 5 x ULN, bilirubin > 2 x ULN.
•5.Recent (< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery.
•6.Recent (< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke.
•7.Patients on chronic anticoagulation or on dual anti-platelet treatment.
•8.Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study.
•9.Severe concomitant disease that as per investigator’s judgement is not compatible with participation in the study.

发起方

Institute of Molecular Medicine and Biomedical Research (IMBE)