Working… Menu
Trial record 51 of 56 for:    "Lung Disease" | "Dalteparin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727427
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : August 8, 2019
Information provided by (Responsible Party):
Marcello Di Nisio, G. d'Annunzio University

Brief Summary:

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 or disease Intervention/treatment
Unsuspected Pulmonary Embolism Drug: Heparin, fondaparinux, vitamin-K antagonists, aspirin

Layout table for study information
Study Type : Observational
Actual Enrollment : 695 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
Study Start Date : November 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Anticoagulants, aspirin
Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; 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)
  • Dabigatran (Pradaxa)
  • Rivaroxaban (Xarelto)
  • Apixaban (Eliquis)

Primary Outcome Measures :
  1. Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis [ Time Frame: one year ]

    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 :
  1. Major, clinically relevant non-major bleeding, and minor bleeding [ Time Frame: one year ]

    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:
  1. Mortality [ Time Frame: one year ]
    Overall mortality

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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.

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 identifier (NCT number): NCT01727427

  Show 46 Study Locations
Sponsors and Collaborators
G. d'Annunzio University
Layout table for investigator information
Principal Investigator: Marcello Di Nisio, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Layout table for additonal information
Responsible Party: Marcello Di Nisio, Principal Investigator, G. d'Annunzio University Identifier: NCT01727427     History of Changes
Other Study ID Numbers: 215/2012
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Keywords provided by Marcello Di Nisio, G. d'Annunzio University:
pulmonary embolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Vitamin K
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors