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Completed

NCT Number: NCT03099031

Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)

The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)

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Key information

Conditions

Venous Thromboembolism Blood Protein Disorders Bone Marrow Diseases Breast Diseases Breast Neoplasms Cardiovascular Diseases Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Leukemia Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Multiple Myeloma Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Thromboembolism Thrombosis Urogenital Diseases Urogenital Neoplasms Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

George Pompidou European Hospital

Paris, France

About this study

The Ottawa score is a clinical predictive score aiming at stratifying thromboembolic recurrences in cancer patients according to identified clinical risk factors and histological type of the tumor. This score has never been validated externally in a prospective way in patients treated with tinzaparin. The objective of this observational prospective study is to enroll cancer patients with TED treated with tinzaparin for a planned period of 6 months and to collect data on thromboembolic recurrences, major hemorrhages, deaths and heparin-induced thrombocytopenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cancer patients with histologically confirmed, active or evolving, solid or liquid tumour, or
  • Suspected malignant tumour confirmed within a month of index VTE occurrence
  • Treated with specific metastatic or adjuvant anti-cancer treatment
  • Patients with recent diagnosis of documented symptomatic or incidental VTE and a prescription of tinzaparin for 6 months
  • Proximal or distal VTE of lower limbs
  • Pulmonary embolism
  • Inferior or superior vena cava thrombosis
  • Iliac vein thrombosis

Exclusion criteria

  • Skin cancer other than melanoma
  • Life expectancy less than 6 months
  • Superficial isolated thrombosis
  • Isolated subsegmental pulmonary embolism
  • Cerebral, visceral thrombosis
  • Superior limbs VTE or Central catheter thrombosis
  • Patients being treated with anticoagulants by more than 7 days

Treatment and study plan

tinzaparin

Drug

Subcutaneous injection of 175 IU/kg once daily for 6 months

Other names: Innohep®

Primary outcomes

  1. Venous thromboembolism recurrence

    Time frame: 6 months

Secondary outcomes

  1. Major hemorrhage

    Time frame: 6 months

  2. Death

    Time frame: 6 months

    All cause mortality

  3. Heparin induced thrombocytopenia

    Time frame: 6 months

Other outcomes

  1. Premature treatment discontinuation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)

Acronym: PREDICARE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
Dec 16, 2019

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.

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