2024-520043-17-00Not yet recruitingPhase 3
The impact of Thromboprophylaxis on Progression Free Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
•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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 6 Dec 2024
- Start date
- 11 Apr 2022
- Lead sponsor
- Institute Of Molecular Medicine And Biomedical Research
- Diseases
- Pancreatic cancer
- EU CT number
- 2024-520043-17-00
- EudraCT number
- 2021-005530-42
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 450
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or spread pancreatic cancer who are about to start first treatment with chemotherapy (NabG). It studies whether a blood-thinning drug, tinzaparin, to prevent blood clots affects how long the disease stays stable.
- Age
- From 18 years. The record also lists an upper age limit of 64 years.
- Sex
- All sexes can join.
- Disease stage
- Pancreatic cancer that has grown locally and cannot be removed, or has spread (metastatic), confirmed by tissue and imaging tests. General fitness score (ECOG) 0-2. Life expectancy more than 6 months.
- Earlier treatment
- No earlier chemotherapy for this cancer: the person plans to start first-line chemotherapy with NabG.
Main reasons for not taking part
- Cannot take blood thinners, for example allergy, past heparin-induced low platelets (HIT II), active major bleeding or septic endocarditis
- Poor kidney function (creatinine clearance below 20 mL/min) or platelet count below 50 G/L
- Poor liver function (AST/ALT above 5 x ULN or bilirubin above 2 x ULN)
- Surgery in the last month, or heart attack, other artery clot or stroke in the last month
- Already on long-term blood thinners or dual anti-platelet treatment, or pregnant or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Other
- Pregnancy/lactation or insufficient contraception during the study and up to 3 months after the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Athens Medical Group, Psychiko Clinic | athens | Greece | Not yet recruiting |
| 401 General Military Hospital of Athens | Athens | Greece | Not yet recruiting |
| Attikon University Hospital | Athens | Greece | Not yet recruiting |
| Theageneio Cancer Hospital | Thessaloniki | Greece | Not yet recruiting |
| Bioclinic S.A. | Thessaloniki | Greece | Not yet recruiting |
| Papageorgiou Hospital | Thessaloniki | Greece | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.