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

NCT ID: NCT03099031

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-15

Brief Summary

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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

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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

Conditions

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Venous Thromboembolism

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tinzaparin

Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism

Tinzaparin

Intervention Type DRUG

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

Interventions

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Tinzaparin

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

Intervention Type DRUG

Other Intervention Names

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Innohep®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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G Meyer, Professor

Role: PRINCIPAL_INVESTIGATOR

Service de pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, Paris

F Scotte, Dr

Role: PRINCIPAL_INVESTIGATOR

Unité fonctionnelle de soins oncologiques de support, Hôpital Européen Georges Pompidou, Paris

Locations

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George Pompidou European Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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NIS-INNOHEP-1093

Identifier Type: -

Identifier Source: org_study_id