EUCTR2021-005530-42-GR
Active, not recruiting
Phase 1
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 sites450 target enrollmentNovember 12, 2021
ConditionsThromboprophylaxis in patients with advanced pancreatic cancerMedDRA version: 20.0Level: PTClassification code 10043607Term: ThrombosisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 21.1Level: PTClassification code 10068067Term: Tumour thrombosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Thromboprophylaxis in patients with advanced pancreatic cancer
- Sponsor
- Institute of Molecular Medicine and Biomedical Research (IMBE)
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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