Clinical trial · Observational
Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure
- 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)
Myeloproliferative neoplasms (MPN) such as Polycythemia Vera (PV) and, Essential Thrombocythaemia (ET) are rare clonal myeloid neoplasms associated with an increased risk of both venous and arterial thrombosis. Thrombotic complications are the main determinant of morbidity and in a less extend mortality. Routine haemostasis analysis (TP, aPTT) are usually normal and are useless to demonstrate a hypercoagulable state. However, previous evidence suggests that global coagulation tests such as thrombin generation or thromboelastometry are able to detect signs of procoagulant imbalance in MPN. Similarly, current data seems to demonstrate that fibrin clot properties (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an hypercoagulable state. Goals of PV and ET treatments are to control blood count to reduce the risk of thrombotic events. Moreover, new drugs such as Janus Kinase Inhibitors (JAKi) were recently licensed for PV and are under investigations on clinical trial for ET. It is currently unknown if treatments that were used for ET and PV, and especially JAKi are able to modify the hypercoagulable state that is observed in those diseases, and if there is difference between drugs. To evaluate impact of MPN treatment on prothrombotic haemostatic profile, we propose to evaluate global coagulation and fibrin clot properties in MPN, depending on the treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
| Thrombocythemia, Essential | Essential Thrombocythemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No cytoreductive vs cytoreductive drugs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PV
- description
- Patients with a diagnosis of polycythaemia vera.
- interventionNames
- Drug: No cytoreductive vs cytoreductive drugs
- label
- ET
- description
- Patients with a diagnosis of essential thrombocythaemia.
- interventionNames
- Drug: No cytoreductive vs cytoreductive drugs
Primary outcomes (3)
- measure
- Fibrin polymerization; lag-time (in seconds)
- timeFrame
- At time of inclusion
- description
- Fibrin polymerization will be assessed by turbidity assay on plasma. Fibrin polymerization will be monitored at 340 nm after incubation with human thrombin and CaCl2. Results will report lag-time (seconds).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All men and women, older than 18 years, with a diagnosis of PV or ET (primary or secondary) according to the 2008 World Health Organization (WHO) classification. Exclusion Criteria: * Lack of participant's consent; * Concomitant treatment with anticoagulant drugs (anti-vitamin K, heparin or direct oral anticoagulant drugs); * Active cancer other than non-melanoma skin cancer (defined as cancer diagnosis \<5 years or treatment \<2 years); * Recent infection (\<30d); * Recent surgery (\<30d); * Recent hospitalization (\<30d); * Recent thromboembolic or cardiovascular event (\<3m).
References
Publications (0)
Data not yet available