The impact of Thromboprophylaxis on Progression Free Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) study
Key facts
- Where
- athens, Athens és Thessaloniki, GörögországSee the 6 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Görögország
- Athens Medical Group, Psychiko Clinicathens, GörögországToborzás még nem indult
- 401 General Military Hospital of AthensAthens, GörögországToborzás még nem indult
- Attikon University HospitalAthens, GörögországToborzás még nem indult
- Bioclinic S.A.Thessaloniki, GörögországToborzás még nem indult
- Papageorgiou HospitalThessaloniki, GörögországToborzás még nem indult
- Theageneio Cancer HospitalThessaloniki, GörögországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute Of Molecular Medicine And Biomedical Research
- Trial code
- EU 2024-520043-17-00
- Record updated
- 2025. január 23.
- Original description
•Evaluate the impact of VTE prevention on progression-free survival (PFS). •Investigate the efficacy of long term VTE prevention with simultaneously administration of tinzaparin during 1st line chemotherapy in patients undergoing anticancer treatment with NabG for locally advanced or metastatic PC.Read full original descriptionShow less
•Evaluate the impact of VTE prevention on progression-free survival (PFS). •Investigate the efficacy of long term VTE prevention with simultaneously administration of tinzaparin during 1st line chemotherapy in patients undergoing anticancer treatment with NabG for locally advanced or metastatic PC.
Inclusion: Locally Advanced or metastatic PC (confirmed by the recommended histological and imaging methods); Age ≥ 18 years; Planning to start 1st line chemotherapy with NabG; Eastern Cooperative Group (ECOG) 0-2; Life expectancy >6 months; Written informed consent.
Exclusion: Recent (< 1 month) oncological surgery, major abdominal or thoracic surgery, major orthopedic surgery, vascular surgery; Severe concomitant disease that as per investigator's judgement is not compatible with participation in the study; 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; Recent (< 1 month) acute coronary syndrome or any other arterial thrombosis, thrombotic or hemorrhagic stroke; Creatinine clearance <20 mL/min according to Cockcroft-Gault formula; Platelet count < 50 G/L at inclusion; Hepatic dysfunction defined as at least one of the following: AST and/or ALT > 5 x ULN, bilirubin > 2 x ULN; Patients on chronic anticoagulation or on dual anti-platelet treatment; Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study.