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PENELOPE Observational Study: Prophylaxis and Treatment of Arterial and Venous Thromboembolism

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ClinicalTrials.gov Identifier: NCT01855698
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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 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.

Condition or disease Intervention/treatment
Hematologic Neoplasm Acute Leukemia Myelodysplastic Syndrome Lymphoma Multiple Myeloma Other: Observation

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Practice in the Prophylaxis and Treatment of Arterial and Venous Thromboembolism in Patients With hEmatological NEoplasms and LOw PlatElets (PENELOPE Observational Study)
Actual Study Start Date : June 2013
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : March 15, 2018


Group/Cohort Intervention/treatment
All patients registered Other: Observation



Primary Outcome Measures :
  1. Number of patients with progression of thrombosis. [ Time Frame: At three months from diagnosis. ]

    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.

  2. Type of management strategy (including observation). [ Time Frame: At three months from enrolment. ]
  3. Dosage of the antithrombotic drugs. [ Time Frame: At three months from enrolment. ]

Secondary Outcome Measures :
  1. Number of different types of hematologica neoplasms. [ Time Frame: At patient enrolment ]
  2. Number of types of arterial or venous thrombosis. [ Time Frame: At three months from enrolment. ]
  3. Level of platelet count. [ Time Frame: At three months from enrolment. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Because this study is designed to provide as wide a picture of the different clinical management strategies in unselected patients with hematologic neoplasms, inclusion criteria are set deliberately wide.

All consecutive subjects that present to the centre and satisfy the inclusion criteria will be considered as potential candidates for enrolment.

There is no age limit for including the patients in the study.

Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855698


Locations
Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
Ancona, Italy
Divisione di Immunoematologia e Medicina Trasfusionale & Centro Trombosi - A.O. Papa Giovanni XXIII
Bergamo, Italy
US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo
Castelfranco Veneto, Italy
Unità Operativa Complessa) - Medicina Generale - Sezione di Ematologia - Ospedale Versilia USL 12 Toscana
Lido di Camaiore, Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina, Italy
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori!"
Monza, Italy
Ospedale San Gennaro - ASL Napoli 1
Napoli, Italy
U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone"
Palermo, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, Italy
Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
Pavia, Italy
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
Pisa, Italy
Ematologia - Ospedale San Carlo
Potenza, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma, Italy
Divisione Ematologia - Università Campus Bio-Medico
Roma, Italy
Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
Roma, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
Università Cattolica di Roma
Roma, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy
Università degli Studi - Policlinico di Tor Vergata
Roma, Italy
UOC Medicina Trasfusionale e Cellule Staminali Azienda Ospedaliera San Camillo Forlanini
Roma, Italy
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Torino, Italy
ULSS N. 6 Osp. S. Bortolo
Vicenza, Italy
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Study Chair: Valerio De Stefano Institute of Hematology, Catholic University, Rome

Additional Information:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01855698     History of Changes
Other Study ID Numbers: EMATO0213
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
hematologic neoplasm, profhylaxis, arterial and venous thromboembolism

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Myelodysplastic Syndromes
Preleukemia
Thromboembolism
Venous Thromboembolism
Hematologic Neoplasms
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Embolism and Thrombosis
Neoplasms by Site