Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

April 26, 2017 updated by: Remedios Otero Candelera, Delos Clinical

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

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.

Study Overview

Status

Completed

Conditions

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 A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn.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

Study Type

Observational

Enrollment (Actual)

352

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence thromboembolisms
Time Frame: 3 months
Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression
3 months
Recurrence thromboembolisms
Time Frame: 6 months
Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemorrhagic events
Time Frame: 6 months
Hemorrhagic events due to LMWH treatment
6 months
Thromboembolic event attributable death
Time Frame: 6 months
Death related to embolic event
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delos Clinical

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2015

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hispalis study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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