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

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

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®)

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 420

Contacts and Locations

Study Locations

• France
  • Paris, France
    • George Pompidou European Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Innohep®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Venous thromboembolism recurrence	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major hemorrhage		6 months
Death	All cause mortality	6 months
Heparin induced thrombocytopenia		6 months

Other Outcome Measures

Outcome Measure	Time Frame
Premature treatment discontinuation	6 months

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): May 15, 2017
• Study Completion (Actual): May 15, 2017

Study Registration Dates

• First Submitted: March 1, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: lymphoma; thromboembolism; anticoagulants; breast neoplasms; colorectal neoplasms; lung neoplasms; neoplasms; venous thrombosis; multiple myeloma; leukemia; digestive system neoplasms; vascular disease; urogenital neoplasms; prostatic neoplasms; Ottawa score; tinzaparin; low-molecular weight heparin; hemostatic disorders; genital neoplasms; intestinal neoplasms; lymphoproliferative disorders; myeloproliferative disorders; lymphatic disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: NIS-INNOHEP-1093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No