Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

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.

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Key information

Conditions

Venous Thromboembolism Cancer Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pulmonary Embolism Pulmonary Thromboembolisms Respiratory Tract Diseases Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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 A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Recurrence thromboembolisms

Time frame: 3 months

Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression
Recurrence thromboembolisms

Time frame: 6 months

Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression

Secondary outcomes

Hemorrhagic events

Time frame: 6 months

Hemorrhagic events due to LMWH treatment
Thromboembolic event attributable death

Time frame: 6 months

Death related to embolic event

Sponsors and collaborators

Lead sponsor

Delos Clinical

Other

Registry information

Official study title

Time of Treatment With Low Molecular Weight Heparins in Cancer Patients With Thromboembolic Disease. Procoagulant Role of Phospholipid-dependent Microparticles.

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: May 1, 2017
Registry last updated: May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed