Status:
COMPLETED
PENELOPE Observational Study: Prophylaxis and Treatment of Arterial and Venous Thromboembolism
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Hematologic Neoplasm
Acute Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
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 x1...
Detailed Description
Illness treatment overview The incidence of venous thromboembolism (VTE) among patients with haematological malignancies has been recently reviewed (1). For patients with lymphoma, the incidence of VT...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01855698
Start Date
June 1 2013
End Date
March 15 2018
Last Update
March 22 2018
Active Locations (23)
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1
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
2
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
Ancona, Italy
3
Divisione di Immunoematologia e Medicina Trasfusionale & Centro Trombosi - A.O. Papa Giovanni XXIII
Bergamo, Italy
4
US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo
Castelfranco Veneto, Italy