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CompletedNCT03134820Updated May 1, 2017

Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

An observational study in Venous Thromboembolism, Pulmonary Thromboembolisms and Cancer, sponsored by Delos Clinical. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-01.

Sponsored by Delos Clinical · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
352
Ages
18 Years and older
Sex
All
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Study 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.

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 A set of exclusion criteria is being used to determine in which patients LMWH will be withdrawn.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

  • Venous Thromboembolism
  • Pulmonary Thromboembolisms
  • Cancer

Keywords

  • Low molecular weight heparins
  • Procoagulants
  • Phospholipid-dependent Microparticles
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In context

Pulmonary Embolism

738 studies on the registry are indexed under Pulmonary Embolism; 158 are open to participants now.

This study's enrollment of 352 is close to the median of 383 across 323 observational studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

This is the only study on the registry with Delos Clinical as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
352 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Recurrence thromboembolisms

    Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression

    Time frame: 3 months

  2. Recurrence thromboembolisms

    Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression

    Time frame: 6 months

Secondary outcomes

  1. Hemorrhagic events

    Hemorrhagic events due to LMWH treatment

    Time frame: 6 months

  2. Thromboembolic event attributable death

    Death related to embolic event

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03134820
Lead sponsor
Delos Clinical
Responsible party
Remedios Otero Candelera (MD Ph D, Hospitales Universitarios Virgen del Rocío) — Principal investigator
First posted
May 1, 2017
Start date
Dec 15, 2015
Primary completion
Dec 31, 2016
Completion
Mar 31, 2017
Last update
May 1, 2017

Study contacts

Remedios Otero Candelera, MD PhD
study chair · Hospital Universitario Virgen del Rocío IBIS
Teresa Elias, MD PhD
principal investigator · Hospitales Universitarios Virgen del Rocío
Isabel Blasco, MD
principal investigator · Hospital Universitario Virgen Macarena
Maria Rodriguez, MD
principal investigator · Hospital Universitario de Valme

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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