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

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01855698
First received: May 14, 2013
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
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 Intervention
Hematologic Neoplasm Acute Leukemia Myelodysplastic Syndrome Lymphoma Multiple Myeloma Other: Observation

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • 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.

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

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

Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients registered Other: Observation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855698

Contacts
Contact: Paola Fazi, Dr. p.fazi@gimema.it
Contact: Enrico Crea e.crea@gimema.it

Locations
Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo Not yet recruiting
Alessandra, Italy
Principal Investigator: Laura Contino         
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo Recruiting
Alessandria, Italy
Contact: Laura Contino         
Principal Investigator: Laura Contino         
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI Recruiting
Ancona, Italy
Contact: Serena Rupoli         
Principal Investigator: Serena Rupoli         
Divisione di Immunoematologia e Medicina Trasfusionale & Centro Trombosi - A.O. Papa Giovanni XXIII Recruiting
Bergamo, Italy
Contact: Anna Falanga         
Principal Investigator: Anna Falanga         
US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo Recruiting
Castelfranco Veneto, Italy
Contact: Elisabetta Scarpa         
Principal Investigator: Elisabetta Scarpa         
Unità Operativa Complessa) - Medicina Generale - Sezione di Ematologia - Ospedale Versilia USL 12 Toscana Not yet recruiting
Lido di Camaiore, Italy
Principal Investigator: Paola Lambelet         
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina Not yet recruiting
Messina, Italy
Principal Investigator: Caterina Musolino         
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori!" Recruiting
Monza, Italy
Principal Investigator: N. Carpenedo         
Ospedale San Gennaro - ASL Napoli 1 Recruiting
Napoli, Italy
Contact: Lucia Mastrullo         
Principal Investigator: Lucia Mastrullo         
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" Recruiting
Palermo, Italy
Contact: Sergio Siragusa         
Principal Investigator: Sergio Siragusa         
Cattedra di Ematologia CTMO Università degli Studi di Parma Not yet recruiting
Parma, Italy
Principal Investigator: Cecilia Caramatti         
Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo Recruiting
Pavia, Italy
Principal Investigator: Rosangela Invernizzi         
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia Not yet recruiting
Pisa, Italy
Principal Investigator: Mario Petrini         
Ematologia - Ospedale San Carlo Recruiting
Potenza, Italy
Principal Investigator: Michele Pizzuti         
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia Recruiting
Roma, Italy
Contact: Antonella Ferrari         
Principal Investigator: Antonella Ferrari         
Divisione Ematologia - Università Campus Bio-Medico Recruiting
Roma, Italy
Contact: Giuseppe Avvisati         
Principal Investigator: Giuseppe Avvisati         
Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo Not yet recruiting
Roma, Italy
Principal Investigator: Maria Grazia Garzia         
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Recruiting
Roma, Italy
Contact: Valerio De Stefano         
Principal Investigator: Valerio De Stefano         
Università Cattolica di Roma Not yet recruiting
Roma, Italy
Contact: Valerio De Stefano         
Principal Investigator: Valerio De Stefano, Dr.         
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia Not yet recruiting
Roma, Italy
Principal Investigator: Antonio Chistolini         
Università degli Studi - Policlinico di Tor Vergata Not yet recruiting
Roma, Italy
Principal Investigator: Sergio Amadori         
UOC Medicina Trasfusionale e Cellule Staminali Azienda Ospedaliera San Camillo Forlanini Recruiting
Roma, Italy
Contact: Maria Grazia Garzia         
Principal Investigator: Maria Grazia Garzia         
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino" Recruiting
Torino, Italy
Principal Investigator: Alessandra Borchiellini         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Study Chair: Valerio De Stefano Institute of Hematology, Catholic University, Rome
  More Information

Additional Information:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01855698     History of Changes
Other Study ID Numbers: EMATO0213
Study First Received: May 14, 2013
Last Updated: October 24, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 22, 2017