Clinical trial NCT03099031: Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)
Official title: Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Ottawa score
tinzaparin
low-molecular weight heparin
anticoagulants
venous thrombosis
thromboembolism
hemostatic disorders
vascular disease
neoplasms
breast neoplasms
lung neoplasms
prostatic neoplasms
colorectal neoplasms
genital neoplasms
urogenital neoplasms
intestinal neoplasms
digestive system neoplasms
lymphoma
leukemia
multiple myeloma
lymphoproliferative disorders
myeloproliferative disorders
lymphatic disease
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient population from French general hospitals, anticancer centres, and university hospitals treating more than 1000 cancer patients per year

Brief summary: 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®)

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Venous thromboembolism recurrence
timeFrame: 6 months
Secondary outcomes:
measure: Major hemorrhage
timeFrame: 6 months
measure: Death
timeFrame: 6 months
measure: Heparin induced thrombocytopenia
timeFrame: 6 months
Other outcomes:
measure: Premature treatment discontinuation
timeFrame: 6 months
Locations:
city: Paris
country: France
facility: George Pompidou European Hospital
Study officials:
affiliation: Service de pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, Paris
name: G Meyer, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité fonctionnelle de soins oncologiques de support, Hôpital Européen Georges Pompidou, Paris
name: F Scotte, Dr
role: PRINCIPAL_INVESTIGATOR
References: