Clinical trial · Observational
PENELOPE Observational Study: Prophylaxis and Treatment of Arterial and Venous Thromboembolism
Clinical Practice in the Prophylaxis and Treatment of Arterial and Venous Thromboembolism in Patients With hEmatological NEoplasms and LOw PlatElets (PENELOPE Observational Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of the study is to assess efficacy and safety of different prophylactic or therapeutic antithrombotic approaches in patients with hematologic neoplasms and platelet count \<50 x109/L, including unfractionated or low molecular weight heparin, fondaparinux, anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants, fibrinolytic agents, with or without a policy of platelet transfusion. Cases with arterial or venous thromboembolism managed with observation or use of vena cava filters in patients with venous thromboembolism will be included too.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Hematologic Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All patients registered
- interventionNames
- Other: Observation
Primary outcomes (3)
- measure
- Number of patients with progression of thrombosis.
- timeFrame
- At three months from diagnosis.
- description
- In patients with hematologic neoplasms and platelet count \<50 x109/L having had diagnosis of arterial or venous thromboembolism and undergoing different therapeutic approaches the following events will be recorded: * Progression of thrombosis during 3 months from diagnosis; * Novel thrombotic events in other sites during 3 months from diagnosis; * Major bleeding during 3 months from diagnosis; * Fatal thrombosis or bleeding; * Non-vascular death. In patients with hematologic neoplasms and platelet count \<50 x109/L undergoing antithrombotic prophylaxis the following events will be recorded: * Thrombotic events during 3 months from the start of prophylaxis; * Major bleeding during 3 months from the start of prophylaxis; * Fatal thrombosis or bleeding; * Non-vascular death.
- measure
- Type of management strategy (including observation).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: * diagnosis of hematologic neoplasm (acute leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic myeloid leukemia, Ph-negative chronic myeloproliferative neoplasms) independently of the stage of disease or treatment (including transplant procedures); * platelet count \<50 x109/L at the time of starting antithrombotic prophylaxis or * platelet count \<50 x109/L at the time of diagnosis of arterial or venous thromboembolism objectively proven or * platelet count \>50 x109/L at time of thrombosis but subsequent thrombocytopenia \<50 x109/L while receiving antithrombotic treatment; * diagnosis of arterial thrombosis include acute coronary syndrome, ischemic stroke (including major and minor stroke), peripheral arterial thrombosis, retinal arterial thrombosis; * diagnosis of venous thrombosis include thrombosis of deep veins of the limbs and the abdomen, superficial veins of limbs, cerebral and splanchnic veins, retinal vein, and pulmonary embolism. Splanchnic venous thrombosis include occlusion of hepatic, portal, mesenteric, and splenic veins. Exclusion Criteria: The following situations will not be criteria of inclusion neither outcomes of interest: * transient ischemic attack without CT and/or NMR signs; * superficial vein thrombosis without Doppler ultrasound examination showing evidence of thrombosis; * antithrombotic prophylaxis only local for central venous lines (i.e. CVC flushing with heparin); * occlusion of the central venous catheter (notice that CVC-related deep venous thrombosis, i.e. thrombosis of the deep veins where the central line is placed, will be a criterion of inclusion or an outcome of antithrombotic prophylaxis).
References
Publications (0)
Data not yet available