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Trial record 27 of 56 for:    "Lung Disease" | "Dalteparin"

Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

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ClinicalTrials.gov Identifier: NCT03134820
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Remedios Otero Candelera, Hospitales Universitarios Virgen del Rocío

Brief Summary:

Cancer is the most important acquired risk factor of thromboembolisms. More than 20% of all episodes of venous thromboembolism (VT) or pulmonary thromboembolisms (PT) are cancer related. Cancer patients with VT or PT are treated with low molecular weight heparins (LMWH) during at least 3 months, but nowadays the duration of treatment is not accurately determined.

The D-Dimer determination has been used like recurrence predictors after LMWH treatment suspension, but in cancer patients the useful is limited. Phospholipid-dependent microparticles could been used like recurrence predictors in cancer patients and tailored the duration of LMWH treatment for each patient.


Condition or disease
Venous Thromboembolism Pulmonary Thromboembolisms Cancer

Detailed Description:
We are carrying out a study in Cancer-associated-thromboembolism patients in order to decide the suitable anticoagulation time. A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn. Patients are being followed after LMWH withdrawal until 6 months. Blood samples are being taken at baseline (LMWH withdrawal), 3 weeks and 3 months after. We will look for association between several biomarkers and venous thromboembolism recurrences.

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Study Type : Observational
Actual Enrollment : 352 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Time of Treatment With Low Molecular Weight Heparins in Cancer Patients With Thromboembolic Disease. Procoagulant Role of Phospholipid-dependent Microparticles.
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners




Primary Outcome Measures :
  1. Recurrence thromboembolisms [ Time Frame: 3 months ]
    Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression

  2. Recurrence thromboembolisms [ Time Frame: 6 months ]
    Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression


Secondary Outcome Measures :
  1. Hemorrhagic events [ Time Frame: 6 months ]
    Hemorrhagic events due to LMWH treatment

  2. Thromboembolic event attributable death [ Time Frame: 6 months ]
    Death related to embolic event


Biospecimen Retention:   Samples Without DNA
Blood samples


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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
Patient with diagnosis of cancer (any) and diagnosis of pulmonary thromboembolism (PT) or venous thromboembolism (VT) , in treatment with low molecular weight heparin (LMWH).
Criteria

Inclusion Criteria:

  • Patient with diagnosis of cancer (any) and diagnosis of pulmonary thromboembolism (PT) or venous thromboembolism (VT) , in treatment with low molecular weight heparin (LMWH).
  • Patients treated with LMWH since cancer diagnostic.
  • Signed informed consent sheet

Exclusion Criteria:

  • Patients with life expectancy lower than 6 months
  • Pregnancy woman
  • Patients with cerebral metastasis

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): NCT03134820


Sponsors and Collaborators
Delos Clinical
Investigators
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Study Chair: Remedios Otero Candelera, MD PhD Hospital Universitario Virgen del Rocío IBIS
Principal Investigator: Teresa Elias, MD PhD Hospitales Universitarios Virgen del Rocío
Principal Investigator: Isabel Blasco, MD Hospital Universitario Virgen Macarena
Principal Investigator: Maria Rodriguez, MD Hospital Universitario de Valme

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Responsible Party: Remedios Otero Candelera, MD Ph D, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT03134820     History of Changes
Other Study ID Numbers: Hispalis study
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Remedios Otero Candelera, Hospitales Universitarios Virgen del Rocío:
Low molecular weight heparins
Procoagulants
Phospholipid-dependent Microparticles
Additional relevant MeSH terms:
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Lung Diseases
Dalteparin
Pulmonary Embolism
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Embolism
Heparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action