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

Sponsor

LEO Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT03099031

Collaborator

(none)

420

Enrollment

Location

24.5

Actual Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Design

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 1, 2015

Actual Primary Completion Date :

May 15, 2017

Actual Study Completion Date :

May 15, 2017

Arms and Interventions

Arm	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®

Arm

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®

Outcome Measures

Primary Outcome Measures

Venous thromboembolism recurrence [6 months]

Secondary Outcome Measures

Major hemorrhage [6 months]
Death [6 months]
All cause mortality
Heparin induced thrombocytopenia [6 months]

Other Outcome Measures

Premature treatment discontinuation [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	George Pompidou European Hospital	Paris		France

Sponsors and Collaborators

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