Time of Treatment With LMWH in Cancer Patients With Thromboembolic Disease

NCT03134820 | Completed

• 1 other identifier: Hispalis study
• Study Type: observational
• Target: 352
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Venous Thromboembolism; Pulmonary Thromboembolisms; Cancer

Keywords

Low molecular weight heparins; Procoagulants; Phospholipid-dependent Microparticles

Outcome Measures

Primary Outcomes (2)

• Recurrence thromboembolisms

  Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression

  3 months

• Recurrence thromboembolisms

  Venous thromboembolisms or Pulmonary thromboembolism recurrence after LMWH suppression

  6 months

Secondary Outcomes (2)

• Hemorrhagic events

  6 months

• Thromboembolic event attributable death

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Delos Clinical: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Venous Thromboembolism; Pulmonary Embolism; Neoplasms

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Remedios Otero Candelera, MD PhD

  Hospital Universitario Virgen del Rocío IBIS

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Ph D

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: December 15, 2015
• Primary Completion: December 31, 2016
• Study Completion: March 31, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share