Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by G. d'Annunzio University
Sponsor:
Information provided by (Responsible Party):
Marcello Di Nisio, G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT01727427
First received: November 7, 2012
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism.

The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.


Condition Intervention
Unsuspected Pulmonary Embolism
Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients

Resource links provided by NLM:


Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis [ Time Frame: one year ] [ Designated as safety issue: No ]

    Suspected recurrent PE with one of the following:

    1. new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram;
    2. new perfusion defect of at least 75% on V/Q lung scan;
    3. inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of DVT in the lower extremities by CUS or venography

    Fatal PE is:

    1. PE based on objective diagnostic testing or autopsy or
    2. death not attributed to a documented cause and for which DVT/PE cannot be ruled out.

    Suspected (recurrent) DVT with one of the following findings:

    1. abnormal CUS;
    2. an intra-luminal filling defect on venography.


Secondary Outcome Measures:
  • Major, clinically relevant non-major bleeding, and minor bleeding [ Time Frame: one year ] [ Designated as safety issue: Yes ]

    Major bleeding will be defined as overt bleeding associated with: a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or bleeding that occurs in a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal or contributing to death.

    Other clinically relevant non-major bleeding will be defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or associated with discomfort for the patient such as pain, or impairment of activities of daily life. All other bleeding events will be classified as minor.



Other Outcome Measures:
  • Mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Overall mortality


Estimated Enrollment: 610
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anticoagulants, aspirin
Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists; aspirin. Any dosage, frequency and duration
Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin
Parenteral or oral anticoagulant Antiplatelet agent
Other Names:
  • Enoxaparin (Clexane)
  • Dalteparin (Fragmin)
  • Nadroparin (Fraxiparin)
  • Tinzaparin (Innohep)
  • Bemiparin (Ivor)
  • Fondaparinux (Arixtra)
  • Warfarin (Coumadin)
  • Acenocoumarol (Sintrom)
  • Phenprocoumon (Marcoumar)
  • Acetylsalicylic acid (Aspirin)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All ambulatory or hospitalized cancer patients with a first diagnosis of unsuspected PE. Both solid and hematological cancers at any stage of disease will be considered for inclusion

Criteria

Inclusion Criteria:

  • cancer patients with a first diagnosis of unsuspected PE

Exclusion Criteria:

  1. age <18 years;
  2. ongoing anticoagulant therapy for previous VTE or indications for long-term anticoagulation other than deep vein thrombosis (DVT) or PE;
  3. life expectancy less than 3 months.
  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: NCT01727427

Contacts
Contact: Marcello Di Nisio, MD, PhD 0039 3283290020 mdinisio@unich.it

Locations
Italy
Marcello Di Nisio Recruiting
Chieti, Italy, 66100
Contact: Marcello Di Nisio, MD, PhD    0039 328 3290020    mdinisio@unich.it   
Sub-Investigator: Ettore Porreca, MD         
Netherlands
Slotervaart hospital Recruiting
Amsterdam, Netherlands, 1066 EC
Contact: Hans-Martin Otten, MD, PhD    +3120 5129333 ext 700    Hans-Martin.Otten@slz.nl   
Principal Investigator: Hans-Martin Otten, MD,PhD         
Sponsors and Collaborators
G. d'Annunzio University
  More Information

No publications provided

Responsible Party: Marcello Di Nisio, Principal Investigator, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT01727427     History of Changes
Other Study ID Numbers: 215/2012
Study First Received: November 7, 2012
Last Updated: November 12, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by G. d'Annunzio University:
Unsuspected
pulmonary embolism
cancer

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fondaparinux
PENTA
Acenocoumarol
Anticoagulants
Heparin
Phenprocoumon
Aspirin
Vitamin K
Vitamins
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014