Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

NCT ID: NCT03134820

Last Updated: 2017-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

352 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-15

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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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 A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn.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.

Conditions

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Venous Thromboembolism Pulmonary Thromboembolisms Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Delos Clinical

OTHER

Sponsor Role lead

Responsible Party

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Remedios Otero Candelera

MD Ph D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Remedios Otero Candelera, MD PhD

Role: STUDY_CHAIR

Hospital Universitario Virgen del Rocío IBIS

Teresa Elias, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospitales Universitarios Virgen del Rocío

Isabel Blasco, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Maria Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Valme

Other Identifiers

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Hispalis study

Identifier Type: -

Identifier Source: org_study_id

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