Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03134820

Enrollment

352

Registered

2017-05-01

Start date

2015-12-15

Completion date

2017-03-31

Last updated

2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Pulmonary Thromboembolisms, Venous Thromboembolism

Keywords

Low molecular weight heparins, Procoagulants, Phospholipid-dependent Microparticles

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.

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 A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn.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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Recurrence thromboembolisms	3 months	Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression

Secondary

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

Outcome results