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)
1 other identifier
observational
99
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2018
CompletedMarch 22, 2018
March 1, 2018
4.8 years
May 14, 2013
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of patients with progression of thrombosis.
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.
At three months from diagnosis.
Type of management strategy (including observation).
At three months from enrolment.
Dosage of the antithrombotic drugs.
At three months from enrolment.
Secondary Outcomes (3)
Number of different types of hematologica neoplasms.
At patient enrolment
Number of types of arterial or venous thrombosis.
At three months from enrolment.
Level of platelet count.
At three months from enrolment.
Study Arms (1)
All patients registered
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Valerio De Stefano
Institute of Hematology, Catholic University, Rome
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2013
First Posted
May 16, 2013
Study Start
June 1, 2013
Primary Completion
March 15, 2018
Study Completion
March 15, 2018
Last Updated
March 22, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share