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

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ClinicalTrials.gov Identifier: NCT03099031
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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®)

Condition or disease Intervention/treatment
Venous Thromboembolism Drug: Tinzaparin

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

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Study Type : Observational
Actual Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)
Actual Study Start Date : May 2015
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : May 15, 2017


Group/Cohort Intervention/treatment
Tinzaparin
Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism
Drug: Tinzaparin
Subcutaneous injection of 175 IU/kg once daily for 6 months
Other Name: Innohep®




Primary Outcome Measures :
  1. Venous thromboembolism recurrence [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Premature treatment discontinuation [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099031


Locations
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France
George Pompidou European Hospital
Paris, France
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: G Meyer, Professor Service de pneumologie et de soins intensifs, Hôpital Européen Georges Pompidou, Paris
Principal Investigator: F Scotte, Dr Unité fonctionnelle de soins oncologiques de support, Hôpital Européen Georges Pompidou, Paris
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03099031    
Other Study ID Numbers: NIS-INNOHEP-1093
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LEO Pharma:
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
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Tinzaparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action